Preparing for Regulatory Submissions

Too often establishing regulatory processes is overlooked early in the design and development process. But the fast and easy route is a mistake. Regardless of the size and stage of your company, you need to comply with regulatory and quality standards. How you choose to tackle regulatory submissions plays a significant role in the overall success and growth of your company.

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A QMS That Sets You Up For Success

Preparing for regulatory submissions isn't an easy feat. In fact, many companies fail the first time. Why? They didn’t get started early enough. Planning ahead, injecting quality into your work, and educating yourself sooner will prepare your teams early so you can go into submissions with confidence. Having a QMS designed specifically for MedTech allows you to navigate the challenges that lay ahead and equips you with the resources you need.

1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

Getting Started With
Regulatory Early

The benefits that come with planning for regulatory submissions as early as possible aren’t initially obvious.

Get Informed

It’s never too early to educate yourself and your teams about the regulatory bodies and processes that directly impact your medical technologies. Being informed means you know what is coming and are prepared for what’s next.

Reduce Errors

Whether you are applying for 510(k) or PMA, it’s easy to get lost in the weeds of what is required. Investing in a QMS designed for the MedTech industry will save you time and money in the future.

Enhance Productivity

Having a QMS that allows your teams to collaborate on essential regulatory documentation increases visibility and promotes a collaborative work culture.

Ensure a Quality Culture

Promote a healthy and successful work culture by equipping your teams with the tools they need to advance. Our annual industry survey indicates a majority of medical device market leaders take extra steps to ensure they promote a quality culture.

How Greenlight Guru Can Help

Uncover all the ways that our end-to-end solution built specifically for the MedTech industry can get you on the right track to prepare for regulatory submissions.

Preparing for Regulatory Submissions Doesn’t Have to be Hard

Greenlight Guru is your solution to manage product development, quality events, and continuous product management so your technologies and teams come out on top.

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Explore Our Resources

Regulatory Submission

Recent FDA Draft Guidances

Episode 343

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Planning an FDA Submission

Episode 342

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Exploring Breakthrough Device Designation

Episode 333

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Regulatory Strategy and the Advantage of Diversity in MedTech

Episode 332

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Validation Toolkit

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Busting Mythconceptions about FDA’s Refuse-to-Accept Policy for Cybersecurity

Informative webinar where participants will learn how to confidently navigate the complexities of FDA cybersecurity requirements and enhance medical device submission strategies.

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3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

Episode 330

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Preparing Your Technical Documentation under MDR: Proven Tips & Techniques

Free webinar presenting proven techniques and tips for medical device companies to prepare technical documentation per Annex II and Annex III of EU MDR, as well as ways to respond ...

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FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Episode 328

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General Safety and Performance Requirements (GSPR) Gap Assessment

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Refuse to Accept (RTA) & Additional Information Requests (AIR): How to Avoid Problems with Your Medical Device Submission

During this webinar we will review the available RTA checklists and participants will learn how to design a submission that will pass administrative review and avoid receiving an ...

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Auditing the Auditor

Episode 298

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5 Tips for IEC 60601 Submissions

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EU MDR Economic Operators Guidance Document

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Tenacore Passes ISO 13485:2016 Recertification Audit with the Help of Greenlight Guru’s Modern Platform

"It’s scalable, it’s repeatable, and it’s audit-ready."

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CDRH Proposed Guidance for FY 2023

Episode 295

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CAPA Report Template

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What "Exempt" Means with Respect to Medical Devices & Regulatory

Episode 292

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FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?

This free, in-depth webinar, presented by regulatory experts Kevin Go and Allison Komiyama, will discuss recent regulatory developments in the Digital Health space, how to apply ...

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We Achieved ISO Certification! Now what?

Episode 290

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Ultimate Guide to Device Class Requirements under EU MDR

In-depth guide on medical device classification and requirements under EU MDR.

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Regulatory Due Diligence: Why Pay for Information You Can Get for Free?

In this free, interactive webinar industry expert Michael Drues, PhD, explains what regulatory due diligence is for medical device professionals and how to do it, as well as how ...

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Building Your Regulatory Strategy for Commercialization

Episode 280

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Overcoming Submission Deficiencies due to Biocompatibility

Episode 278

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Does Your CAPA Process Need a CAPA?

Episode 277

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UDI and the Current State of Global Implementation

Episode 276

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The Changing Job Market & How it Affects Careers for MedTech Quality Professionals

Episode 275

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Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Episode 273

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Global MedTech Regulatory Trends: True Quality Summit Series

MedTech’s global regulatory landscape has changed drastically over the last decade. Policies are evolving across the globe and more programs and processes are being introduced by ...

Regulatory Submission

MDR Transition and Tech File Changes: What Medical Device Companies Need to Know

Register for this free, in-depth webinar presented by Rook Quality Systems Sr. Quality Manager Chandler Thames who will expand on the new MDR requirements, and provide key ...

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Shifting Sands of SaMD Cybersecurity Regulations

Episode 270

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Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

Episode 268

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Software Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry

Episode 265

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Demystifying the De Novo Process

Episode 260

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Challenges for Regulatory Submission: EU vs. US

Episode 259

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How to Survive an FDA Inspection

A free, in-depth webinar covering some preventative actions that a medical device company can take to minimize the possibility of receiving a 483 which in some cases could result ...

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Special Controls: What Are They & How Can We Use Them To Our Advantage?

This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will cover the basics of special controls, how to know if your device needs them and ...

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Navigating the Medical Device Single Audit Program (MDSAP)

Episode 254

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Making Your Informational Meetings With FDA Valuable & Worthwhile

Episode 252

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Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols, MedTech Intelligence

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QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

Episode 250

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Letter-to-File 101: Are You Sure You're Preparing Yours Correctly?

A free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, covering the basics of how to prepare a letter-to-file the right way in order to avoid a ...

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How To Prepare An FDA Pre-Submission

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Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

Episode 246

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A Regulatory Gap Analysis of FDA's Systems & Policies

Episode 244

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Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Episode 242

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UDI Product Data and EUDAMED, Get Onboard!

A free, in-depth webinar covering best practices for UDI preparations and the future potential impacts to medical device manufacturers as EUDAMED requirements are becoming stable.

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The End of EUA Is Coming Soon

By Jon Speer, Medical Product Outsourcing

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How to Ace your Internal Audits in 2022

A free, in-depth webinar explaining how to conduct internal audits of core QMS functions and cross-functional collaboration methods you can use to benefit your product, QA/RA, and ...

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Understanding the UDI System for Medical Devices

Episode 241

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Why FDA Is Prioritizing Clinical Decision Support Software & Why You Should Care

Episode 238

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How to Effectively Implement the New ISO 14971:2019 & Maintain Your Current Risk File

Free, in-depth webinar covering various key changes to ISO14971 and practical approaches for implementation of the new standard for both new products and legacy products.

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Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment

A free, in-depth webinar covering the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and challenges ...

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Breakthrough Device Designation & Its Impact on Reimbursement

A free, in-depth webinar covering the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to market.

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25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

A comprehensive list of most frequently asked questions and their answers about ISO 15223-1:2021 Fourth Edition, the latest version of the international standard for the ...

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The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?

A free, in-depth webinar covering the “new” safety and performance based 510k (sp510k).

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Assessing the Global Regulatory Landscape

Episode 232

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The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing

A free, in-depth webinar covering various additive manufacturing methods and 3D printing technologies companies can use for making medical devices, validating workflows, and ...

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When to Throw the Least Burdensome Flag on FDA

Episode 230

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Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Episode 228

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Abbreviated 510(k) Submission Checklist

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FDA Labeling Requirements Checklist

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Checklist: Premarket Submission Documentation for Devices Containing Software

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Understanding FDA's New Intended Use Rule and its Implications

Episode 223

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FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy

Free, in-depth webinar presented by regulatory experts from the Greenlight Guru Regulatory Advisory Board, where they will compare and contrast FDA versus EU regulatory pathways, ...

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EU MDR Preparedness: How Is COVID-19 a Factor?

By Jon Speer, Medical Product Outsourcing

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Explaining the Role of Importer under EU MDR

Episode 217

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Attention ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update your Medical Device Labeling to Comply with the New Requirements

This free, in-depth webinar will cover the latest updates of ISO 15223-1 4th Edition to help participants understand the full scope of changes and uncover actionable ways to ...

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Preparing Your Pre-Submission with the Content FDA Wants to See

Episode 216

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Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

Episode 213

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Closed-Loop Traceability for FDA Compliance

By Jon Speer, Quality Digest

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Examining the HHS Proposal for Premarket Notification Exemptions

Episode 211

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Regulatory Tips & Pointers from a Former FDA Reviewer

Episode 205

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How to Prepare for and Manage Audits/Inspections across Global Markets

In this free, exclusive webinar event, Greenlight Guru founder Jon Speer will moderate a panel of industry experts in a lively discussion about audits and inspections.

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Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Episode 203

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MDR & IVDR Gap Analysis Toolkit

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Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Episode 202

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Preparing for the EU’s MDR

By Nick Tippmann, Medical Product Outsourcing

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For the Love of Internal Auditing

Episode 199

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What Are the Biggest Changes under EU MDR?

By Jon Speer, MedTech Intelligence

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Understanding the Investigational Device Exemption (IDE) Process

Episode 192

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2021 EU MDR Preparedness Study

In this report, we wanted to provide you with a holistic picture of what other medical device teams are doing to prepare for the upcoming EU MDR deadline and give you a full 60 ...

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Why the PMA Process is so Dreaded by Manufacturers in the US Market

Episode 187

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Everything you Need to Know about SaMD from an FDA Perspective

Episode 183

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EU MDR & IVDR True Quality Summit Series

Whether you've fully transitioned, are just getting started, or are planning to enter the EU market in the future, you won't want to miss this free virtual summit that covers ...

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Preparing for Remote and On-Site Inspections and Audits

Episode 182

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How does EU MDR impact your Quality Management System?

Episode 181

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510(k) Program Comparison Chart

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Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

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Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Episode 179

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Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

Episode 172

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Checklist: 7 Steps to Comply with FDA 21 CFR Part 11

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How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Episode 171

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Traceability Requirements in EU MDR

By Jon Speer, Medical Device and Diagnostic Industry (MD+DI)

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Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Episode 170

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Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common pitfalls.

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Positive and Negative Impacts of EUA on the Medical Device Industry

Episode 167

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When Do We Need FDA’s Permission to Market Our Device and When Do We Not?

A free, in-depth webinar exploring what is and is not a regulated medical device and how manufacturers can interpret and leverage FDA's definition of a device.

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Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

A free, in-depth webinar covering the best tools and tricks for manufacturers of in vitro diagnostic devices to meet IVDR requirements and obtain CE Marking.

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Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Episode 162

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Insider’s look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes

A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can prepare accordingly.

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What are the Audit Etiquette Rules I Should be Following?

Episode 159

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Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

A free in-depth webinar covering the most effective verification and testing strategies companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1.

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3 Tips for Receiving EUA from FDA

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How to Construct an Effective Regulatory Strategy

Episode 148

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510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Episode 145

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[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

Episode 143

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Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

Episode 140

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How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

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Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices

Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox activity.

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Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?

This free in-depth webinar will explore all regulatory pathways to market — including the lesser-known and lesser-used ones — to help you decide which to use when for your medical ...

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What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Episode 136

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How to Choose the Right FDA Regulatory Pathway for your Device

Episode 135

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2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Episode 131

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Six Mistakes to Avoid When Implementing ISO 13485

By Jon Speer, Medical Product Outsourcing

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What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

Episode 129

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IVDR Gap Assessment Tool

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FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Episode 125

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We’re going through changes: Major upcoming regulatory changes for manufacturers explained

By Jon Speer, Medical Plastics News

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Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer, Medtech Intelligence

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Preparing for EU MDR

Episode 124

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A Tsunami of Regulatory Changes is Coming

By Jon Speer, InCompliance

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An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019

A free, in-depth webinar covering the new changes to ISO 14971:2019, the international standard for medical device risk management, and its companion guidance document ISO TR ...

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MDD vs. MDR Gap Assessment Tool

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IEC 60601

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5 Myths about PMA's (and what's actually true)

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Top 4 Mistakes When Implementing ISO 13485

By Jon Speer, Medical Design & Outsourcing

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Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Episode 122

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Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Episode 121

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How And When To Register EU Medical Devices And Report UDI Information To EUDAMED

In this free webinar participants will learn how and when to register EU medical devices and report Unique Device Identification (UDI) information to EUDAMED, manage UDI ...

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Implementing Changes to SaMD under New EU MDR

Episode 118

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The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer, The MedTech Conference

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10 Steps To Preparing Your 510(k) Submission (And How To Avoid The Common Pitfalls)

In this free webinar participants will learn about the key steps to take when preparing a 510(k) Premarket Notification and how to avoid common pitfalls that can occur during this ...

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Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Episode 112

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4 Facts That May Surprise You About FDA

Episode 110

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FDA Warning Letters

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EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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Looking at the Sunset of FDA's Alternative Summary Reporting Program

Episode 108

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21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes

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EU IVDR

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Technical File vs Design Dosier

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Notified Body

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FDA 510k Clearance

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The Essential Guide to Preparing Your QMS for EU MDR

This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.

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EU MDR: Not All Doom and Gloom

Episode 103

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How to Make De Novo a Viable Option for your Medical Device

Episode 101

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FDA Form 483

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Understanding Post-market Surveillance under EU MDR: Being Proactive, Not Reactive

A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, and ...

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MDSAP vs. ISO 13485:2016 Gap Assessment Tool

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Quality Assurance Auditing

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ISO 13485 vs 9001

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GMP Compliance

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What To Expect During an FDA QSIT Inspection

By Jon Speer, Quality Digest

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EU MDR Gap Analysis Tool

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Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

Episode 97

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Unique Device Identification (UDI)

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21 CFR 803 Medical Device Reporting

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Prepping your QMS for EU MDR

A free webinar on the critical steps that are needed in order to prepare your Quality Management System (QMS) for the upcoming EU Medical Device Regulations (EU MDR) in 2020.

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Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Episode 91

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Aligning True Quality and Compliance with MDDAP

Episode 89

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FDA 510(k) Database

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Explaining the Significance of Voluntary Consensus Standards

Episode 88

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EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

Free webinar on how to interpret European Union’s Medical Device Regulation (EU MDR), what it means to each organization, and what you can do to be compliant in the EU.

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MedWatch Form

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Medical Device Regulations

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ISO Medical Device Standards

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MDSAP

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Electronic Medical Device Reporting

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FDA Plans to Modernize 510(k) - Is the Sky Falling?

Episode 86

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Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84

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6 Best Practices for Complying with ISO 13485:2016

By Jon Speer, Medical Product Outsourcing

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Streamlining The Device Marketing Authorization Process

Episode 83

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FDA Partners with Greenlight Guru: Case for Quality Webinar Series

Free webinar series presented by FDA Case for Quality Manager Cisco Vincenty in partnership with Greenlight Guru. This four-part webinar series covers the future of FDA's Case for ...

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ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices

ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS platform ...

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The New Special 510(k)

Episode 82

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What's New With PMAs

Episode 81

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The 510k and Substantial Equivalence: Why do so many get it wrong?

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Medical Device Reporting

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FDA cGMP

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5 FDA 510(k) Submission Mistakes to Avoid

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FDA Program Comparison Table

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5 Tips for a Competitive Regulatory Strategy

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510(k) Submission Checklist

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Cheat Sheet on Preparing Your Team for an FDA Inspection

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5 Ways to Prepare Your Team for an FDA Inspection

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Using Your 510(k) Submission for Design Controls and DHF Table

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5 Key Steps for Getting Your Medical Device CE Mark

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9 Tips for Password Compliance with 21 CFR Part 11

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5 Tips for a Successful 510(k) Submission

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ISO 13485:2016: Changes You Should Know About

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ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table

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FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

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FDA 483/Warning Letter Response Template

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ISO 13485 Audit

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Standards, Standards, Standards – Makes the Medical Device World go Around

Free webinar presented by the FDA and Greenlight Guru. Learn about IMDRF, its forthcoming guidance, and how its priorities play in relation to international medical electrical ...

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Regulatory Tips & Observations from a Former FDA Reviewer

Episode 78

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What You Need to Know About The FDA CDRH Experiential Learning Program

Episode 76

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Latest Updates on CDRH Standards Program and IEC 60601

Episode 75

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FDA's Case for Quality: Non-Product Computer System Validation (Part 4 of 4)

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21 CFR Part 11: A Complete Guide

We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the requirements actually mean ...

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Quality VS Compliance Metrics & What's Next for FDA's Case for Quality Pilot (Part 3 of 4)

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What you Need to know About FDA's Progressive Programs

Episode 72

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The Pre-Market Approval (PMA): Is it really as bad as so many think?

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What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

Episode 71

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Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.

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A Step-by-Step Guide to Preparing Your FDA 510(K) Submission

Looking to submit your FDA 510k? This step by step guide provides step-by-step instructions on preparing an FDA 510(k) submission to gain market clearance.

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FDA's Case for Quality: Voluntary Program and Status Update (Part 2 of 4)

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10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR

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How to Design for Compliance with IEC60601

Episode 66

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ISO 13485 REQUIREMENTS

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FDA Allows Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

Episode 65

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How to Use the Abbreviated FDA 510(K) Pathway to Your Advantage

Episode 64

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Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not be as Scary as You Think)

Episode 63

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FDA's Case for Quality: What, Why and How? Changing the Regulatory Paradigm

Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this means ...

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Why the FDA Presubmission Is an Underutilized Tool

By Jon Speer, Quality Digest

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How To Structure Your Internal Audit Program

By Jon Speer, Med Device Online

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Here’s what you need to know about FDA’s new guidance on software as a medical device

By Jon Speer, MedCity News

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The Countdown to Implementing ISO 13485:2016

By Jon Speer, Medical Device and Diagnostics Industry

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The potential impact of FDA’s use of PRO to assess effects of medical devices

By Jon Speer, MedCity News

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Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

By Jon Speer, Medical Device and Diagnostics Industry

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How to prepare your medical device company for an FDA inspection

By Jon Speer, MedCity News

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7 Common Mistakes That Sink FDA 510(k) Clearance

By Jon Speer, Med Device Online

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How to Prepare Your Design History File For An FDA Inspection

By Jon Speer, Med Device Online

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FDA Audit

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EU MDR

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MEDDEV 2.7/1

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FDA QSR

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510k vs PMA

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FDA 483

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ISO 13485 Standards

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ISO 9001

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CE Marking

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ISO 14971

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ISO 13485

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510K Submission

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21 CFR 820

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21 CFR Part 11

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A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

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Tips, Tricks & Best Practices for Complying with ISO 13485:2016

Episode 62

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What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Episode 57

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Evaluating FDA's "New" Proposed Fast-Track Alternative Approach to the 510(k) Pathway

Episode 56

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What You Need to Know About Medical Electrical Standards Updates

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Advanced Strategies and Tactics for Using the De Novo Pathway

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Common Mistakes That Can Tank Your 510(k) Submission

Episode 53

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How to Use Real-Word Evidence for Medical Device Regulatory Decisions

Episode 52

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Top 10 Most Significant Changes Introduced by the New EU MDR

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How to Prepare for the Medical Device Single Audit Program (MDSAP)

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How to Prepare for (and Make the Most of) Your FDA Pre-Submission

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15 Steps to Get Approval to IEC 60601-1

Regulatory Submission

8 Steps to Implement an EU-MDR Compliance Program

Regulatory Submission

How to Prepare for the New EU Medical Device Regulations (MDR)

Regulatory Submission

How to Simplify Your Compliance to the New ISO 13485:2016

Regulatory Submission

How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

Regulatory Submission

510(k) Submission Tips, Tricks & Timlines from a Former FDA Reviewer

Regulatory Submission

How To Avoid and Respond to FDA 483's and Warning Letters

Regulatory Submission

An Overview of ISO 14971 Risk Management

Regulatory Submission

Understanding the Changes to ISO 13485:2016

Regulatory Submission

How To Prepare for the Transition to ISO 13485:2016

Regulatory Submission

Lessons to Be Learned From Recent FDA Inspections

Episode 51

Regulatory Submission

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

Episode 50

Regulatory Submission

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

Regulatory Submission

Comparing FDA Submission Types: 510(k) VS. De Novo VS. 513(G) VS. Pre-Submission

Episode 48

Regulatory Submission

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Episode 46

Regulatory Submission

How FDA Interacts with Medical Devices When They Are Imported into the US

Episode 41

Regulatory Submission

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Episode 36

Regulatory Submission

4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)

By Jesseca Lyons, Med Device Online

Regulatory Submission

3 Tips to Reduce the Chance of a 510(k) Submission Rejection

By Jesseca Lyons, Medical Product Outsourcing

Regulatory Submission

Six Tips to Make Sure Your 510(k) Submission Is Accepted

By Jon Speer, Quality Digest

Regulatory Submission

6 tips to reduce likelihood of a rejection for an FDA 510(k) submission

By Jon Speer, MedCity News

Regulatory Submission

4 Tips for a Smooth 510(k) Submission Process

By Jon Speer, Medical Device and Diagnostics Industry

Regulatory Submission

ISO 14971 or FMEA: Which Should You Use?

By Jesseca Lyons, Quality Digest

Regulatory Submission

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

By Jon Speer, Quality Digest

Regulatory Submission

Understanding ISO 14971 medical device risk management

By Jon Speer, MedCity News

Regulatory Submission

What were the top reasons FDA issued device makers 483â€™s and warning letters in 2015

By Jon Speer, MedCity News

Regulatory Submission

Get and stay on the FDA's good side with Jon Speer

Inspired Imua Podcast

Regulatory Submission

A Step-by-Step Guide to Complying with Medical Device QMS Requirements

By Jon Speer, Medical Design Technology

Regulatory Submission

5 Tips to Help Your FDA 510(k) Submission (checklist included)

By Jon Speer, MedCity News

Regulatory Submission

How to Prepare for an FDA Inspection

By Jon Speer, Quality Digest

Regulatory Submission

7 Steps to Respond to FDA 483 Inspection Observations

By Jon Speer, MedTech Intelligence

Regulatory Submission

5 tips to help you prepare for an FDA inspection

By Jon Speer, MedCity News

Regulatory Submission

How to make FDA work for you â€“ ATL Device Night

By Nick Tippmann, Mass Device

Regulatory Submission

The $400,000 FDA compliance mistake you donâ€™t want to make

By Jon Speer, MedCity News

Regulatory Submission

Case Study: 5 Mistakes that lead to flushing $400,000 in fighting the FDA

By Jon Speer, OrthoStreams