Clinical Login Support
Products

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

Learn More

Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
BestQMS-book-mockup-01

Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

View Now
Pricing
Contact Sales Get a Demo
Contact Sales
Get a Demo

FREE ON-DEMAND WEBINAR
September 12, 2024

Preparing a Successful FDA Medical Device Submission

Navigating the FDA medical device submission process can present a complex maze of challenges, but with the right approach, it can lead to a faster, more efficient path to market.

In this exclusive webinar, led by a former FDA reviewer, you'll gain insider knowledge and practical strategies to ensure your submission stands out for all the right reasons.

Whether you're a seasoned professional or new to the process, you'll learn actionable insights that will help you avoid costly delays and position your device for a successful review and approval.

Specifically, this webinar will cover:
  • Understanding the FDA Review Process: Get an insider's perspective on what happens when your submission reaches the FDA, so you can anticipate and address potential challenges.
  • Telling Your Product's Story: Learn how to effectively communicate the unique aspects of your device to the review team, ensuring your submission is clear, concise, and compelling.
  • Mastering eSTAR: Discover what eSTAR is and how it can simplify your submission process. We'll guide you through preparing and organizing your submission using this innovative tool.
  • Leveraging Standards and Guidances: Understand how to utilize relevant standards and guidance documents to strengthen your submission and align with FDA expectations.
  • Tips and Tricks for Success: Benefit from expert advice on additional strategies that can help your submission stand out and move smoothly through the review process.

Watch the webinar
Preparing a Successful FDA Medical Device Submission
Who should attend?
  • R&D Engineers and Management
  • Product Development Engineers and Management
  • Quality Professionals and Management
  • Regulatory Affairs Professionals & Management
  • Medical Device Executives
Register Now  

Presented by

Vernon Baker
Moderator:
Vernon Baker

Senior Medical Device Guru,
Greenlight Guru
Michael Nilo round
Presenter:
Michael Nilo

President,
Nilo Medical Consulting Group

NMCG Logo blue_green transparent

Nilo Medical Consulting Group (NMCG) helps clients navigate the US FDA and global regulatory/clinical environments with special expertise in medical devices, diagnostics, and combination products, including comprehensive regulatory submission preparation and CRO services.

Our clients are small to large medical device and biotechnology companies in the design, manufacturing, and/or sales phase of medical device development based in the US, EU, and other geographies. Clients may request regulatory or clinical research program management, submission authorship and/or review, strategic advice on a specific regulatory, clinical, or technical challenge, or surge capacity support. We are also available to teach courses and provide templates to regulatory, quality and clinical affairs professionals, students, or other interested parties.

The regulatory and clinical environments of the medical device industry are constantly evolving. Nilo Medical Consulting Group provides strategic knowledge and hands-on expertise to reduce the complexity of these domains, helping clients successfully navigate the path to market.

Visit their website to learn more.

Greenlight Guru logo

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

Featured In