Guest Thought Leadership Articles

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Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

By Etienne Nichols, Quality Digest

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Three Things MedTech Firms Need to Do for 'True Quality'

By Nick Tippmann, Medical Product Outsourcing

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Top Hiring and Recruiting Tips for Med-Tech Companies

By Nick Tippmann, Medical Product Outsourcing

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True Quality Experts Weigh in on MedTech Future Trends

By Nick Tippmann, Medical Product Outsourcing

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Finding from Greenlight Guru's Benchmark Survey of 519 Medtech Professionals

By Etienne Nichols, Project Medtech Podcast

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Supplier Quality Management: What MedTech Manufacturers Need to Know

By Nick Tippmann, Med-Tech Innovation

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Three Lessons from True Quality 2022

By Nick Tippmann, 24x7 Magazine

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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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The End of EUA Is Coming Soon

By Jon Speer, Medical Product Outsourcing

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Three Ways To Know Your Medical Device Start-Up Is Ready For Your Next Round of Funding

By Nick Tippmann, Medical Product Outsourcing

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4 Red Flags Investors Look For When Vetting Your Medical Device Company

By Nick Tippmann, MedTech Intelligence

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Risk Management for Medical Devices

By Wade Schroeder, Quality Digest

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

By Jon Speer, Medical Product Outsourcing

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How a Medical Device QMS Can Lead to More Efficient and Sustainable Diagnostic Tests

By Brandon Henning, Medical Product Outsourcing

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Closed-Loop Traceability for FDA Compliance

By Jon Speer, Quality Digest

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Preparing for the EU’s MDR

By Nick Tippmann, Medical Product Outsourcing

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What Are the Biggest Changes under EU MDR?

By Jon Speer, MedTech Intelligence

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Using Quality as an Advantage in 2021

By Jon Speer, Medical Product Outsourcing

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Three Reasons Automation and Training Are Essential in Your Medical Device QMS

By Jon Speer, Medical Product Outsourcing

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What Is Quality Culture and Does Your Company Have It?

By Jon Speer, Medical Device and Diagnostic Industry

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Why You Must Have a Single Source of Truth for CAPA

By Jon Speer, MedTech Intelligence

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Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

By Nick Tippmann, Medical Product Outsourcing

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Imagine It’s 2030: What Was the Key To Business Success During COVID-19?

By David DeRam, Inside INdiana Business

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Traceability Requirements in EU MDR

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

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Four Essential Processes in Medical Device Risk Management

By Jon Speer, Quality Digest

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Adopting a Data-Driven Approach to Quality with a Medical Device QMS

By Jon Speer, Medical Product Outsourcing

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The Importance of Managing and Controlling Risk in the Medical Device Industry

By Jon Speer, Quality Digest

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Why I Left a MedTech Manufacturer For a Software Scale-Up

By Wade Schroeder, Inside INdiana Business

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Areas to Consider in Medical Device Risk Management

By Jon Speer, Medical Product Outsourcing

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Ensure Success Throughout the Entire Medical Device Lifecycle

By Jon Speer, Medical Device and Diagnostics Industry

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What Consumer Tech Companies Need To Know About Medical Devices In The European Union

By David DeRam, Forbes

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From the Experts: Best Practices to Ensure Device Success

By Jon Speer, Medical Product Outsourcing

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Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic

By Jon Speer, MedTech Intelligence

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Managing and Leading Medical Device Companies and Teams During the Pandemic

By Jon Speer, Medical Product Outsourcing

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COVID-19’s Impact on the MedTech Industry: How to Get Through

By Jon Speer, MedTech Intelligence

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What You Need to Know for an Effective Risk Assessment

By Jon Speer, Quality Digest

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What Consumer Tech Companies Need To Know About Medical Devices In The US

By David DeRam, Forbes

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Engineers: How to Curb Quality Myths Now

By Jon Speer, MedTech Intelligence

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Building a Medtech Firm on a Foundation of Quality

By Nick Tippmann, Medical Product Outsourcing

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Paper Processes: Three Reasons It’s a Costly Business Move

By Jon Speer, MedTech Intelligence

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Paper Is Expensive

By Jon Speer, Quality Digest

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The True Cost of Paper

By Jon Speer, Medical Product Outsourcing

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4 Powerful Ways Mindfulness Encourages Peak Performance

By David DeRam, Forbes

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Why Great Companies Don't Run On Spreadsheets

By David DeRam, Forbes

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3 Keys to Attracting Investors and Raising Funds for Your Med Device

By Jon Speer, Healthcare Business Today

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Six Mistakes to Avoid When Implementing ISO 13485

By Jon Speer, Medical Product Outsourcing

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5 Tips To Raise Funding For Your Medical Device

By Jon Speer, Medical Design & Outsourcing

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5 Tips to Raise Investor Interest and Fund Your Medical Device

By Jon Speer, Medical Product Outsourcing

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4 Keys to Funding Your Medical Device

By Jon Speer, MedTech Intelligence

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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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A Tsunami of Regulatory Changes is Coming

By Jon Speer, InCompliance

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Top 4 Mistakes When Implementing ISO 13485

By Jon Speer, Medical Design & Outsourcing

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Five Tips From Medtech Executives on the Value of Quality

By Jon Speer, Quality Digest

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The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer, The MedTech Conference

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Not All Medical Device QMS Solutions Are Created Equal

By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing

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Quality Is The Heartbeat Of Your Company

By David Deram, Forbes

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Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer, Quality Digest

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Choosing The Right QMS For Your Medical Device Company

By Evan Luxon, Centese (Greenlight Guru customer), MedTech Intelligence

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The Most Common Problems With Your CAPA Process

By Jon Speer, ECN

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What To Expect During an FDA QSIT Inspection

By Jon Speer, Quality Digest

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Top 26 Medical Device Conferences To Attend in 2019

By Jon Speer, ECN Magazine

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Creating an It Factor Culture

By David Deram, The Sales Evangelist

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2019 MedTech Predictions

By Jon Speer, MedTech Intelligence

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6 Best Practices for Complying with ISO 13485:2016

By Jon Speer, Medical Product Outsourcing

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Why Paper-Based Systems No Longer Make the Cut

By David DeRam, MedTech Intelligence

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5 Tips for Post-Market Medical Device Compliance

By Jon Speer, Medical Design & Outsourcing

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Why Cloud Software Companies Should Build for Vertical Industries

By David DeRam, DZone

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5 Reasons Design Controls and Risk Management Processes Fail

By Jon Speer, Medical Product Outsourcing

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Cloud Companies Should Build for Vertical Industries

By David DeRam, InformationWeek

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How to Avoid a Medtech Document Scavenger Hunt

By Jon Speer, MedCity News

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Five Common Mistakes Companies Make With CAPA

By Jon Speer, Quality Digest

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Why the FDA Presubmission Is an Underutilized Tool

By Jon Speer, Quality Digest

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A timeline to adopt medical device QMS (and why you need to act now)

By Jon Speer, MedCity News

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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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Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups — Here Are 5 Tips You Can Steal

By David DeRam, Business 2 Community

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How to streamline the customer complaint handling process

By Jon Speer, Medical Design & Outsourcing

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The Impact of Risk Management on CAPA

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

The Countdown to Implementing ISO 13485:2016

By Jon Speer, Medical Device and Diagnostics Industry

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Greenlight Guru Revenue Rockets In Q4, Plans Hiring Spree In Q1

By Greenlight Guru, Med Device Online

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How to Integrate Complaint Handling and Risk Management

By Jon Speer, Quality Digest

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5 things to address if you’re a medical device startup

By Jon Speer, Med-Tech Inovation

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What should really trigger a CAPA?

By Jon Speer, Medical Design & Outsourcing

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Why the best engineers are attracted to big problems

By David Odmark, Techpoint

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5 predictions for the medical device industry in 2018 (and how you can prepare)

By Jon Speer, MedCity News

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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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How CAPA Connects to Other QMS Processes

By Jon Speer, Quality Digest

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What a Risk-Based QMS Means

By Jon Speer, Quality Digest

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5 Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer, Diagnostic and Interventional Cardiology

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The 5 Most Common Problems With Your CAPA Process

By Jon Speer, Med Device Online

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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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Design Validation vs. Clinical Evaluation: What's the difference?

By Jon Speer, Quality Digest

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How to prepare your medical device company for an FDA inspection

By Jon Speer, MedCity News

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Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer, Mass Device

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Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer, Medical Design & Outsourcing

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7 Common Mistakes That Sink FDA 510(k) Clearance

By Jon Speer, Med Device Online

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Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups -- Here Are 5 Tips You Can Steal

By David DeRam, Entrepreneur

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Thought Leadership Article

How to Debunk the Most Common CAPA Myths

By Jon Speer, The MedTech Conference

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Proper Design Controls Could Save You $20 Million

By Jon Speer, Medical Product Outsourcing

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Why Your Medical Device QMS Should Match the Size of Your Company

By Jon Speer, Quality Digest

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15 Startup Secrets You Can Steal From Sports Cultures

By David DeRam, Powderkeg

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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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Debunking 8 commonly held CAPA myths

By Jon Speer, MedCity News

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Thought Leadership Article

Medical device product development: pitfalls you need to avoid

By John Speer, MassDevice

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Thought Leadership Article

Medical device product development: 7 pitfalls you need to avoid

By Jon Speer, Medical Design & Outsourcing

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Four Ways to Build an Elite Team (On or Off The Field)

By David DeRam, Inside INdiana Business

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What are the best ways to handle medical device customer complaints?

By Jon Speer, MedCity News

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What should trigger a CAPA in medical device manufacturing?

By Jon Speer, MedCity News

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Thought Leadership Article

Correcting misconceptions about FDA design controls for the medical device industry

By Jon Speer, MedCity News

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Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'

By John Speer, Medical Device and Diagnostic Industry

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4 key compliance issues for medical device companies

By Jon Speer, MedCity News

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Five Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer, Quality Digest

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5 predictions for the medical device industry

By Jon Speer, MedCity News

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Key Challenges for Risk Management in Medical Device Development

By Jon Speer, Quality Digest

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3 tips for managing your medical device design history file

By Jon Speer, MedCity News

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

By Jesseca Lyons, Med Device Online

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Thought Leadership Article

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

By Jesseca Lyons, Medical Product Outsourcing

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

By Jon Speer, Quality Digest

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

By Jon Speer, MedCity News

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Thought Leadership Article

4 Tips for a Smooth 510(k) Submission Process

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

ISO 14971 or FMEA: Which Should You Use?

By Jesseca Lyons, Quality Digest

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First-In-Human Studies - What's The Rush?

By Jon Speer, Med Device Online

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Debunking 4 commonly held design control myths

By Jon Speer, MedCity News

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Thought Leadership Article

Navigating the difficult road of medical device product development while avoiding the common pitfalls

By Jon Speer, MedCity News

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Eight Reasons Why Your Design Controls and Risk Management Processes Fail

By Jon Speer, Quality Digest

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Thought Leadership Article

Understanding ISO 14971 medical device risk management

By Jon Speer, MedCity News

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Thought Leadership Article

3 tips for applying risk management across medical device product development

By Jon Speer, MedCity News

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Thought Leadership Article

The Definitive Guide to Responding to FDA 483 and Warning Letters

By Jon Speer, Medical Design Technology

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Thought Leadership Article

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

By Jon Speer, MedCity News

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8 Reasons Design Controls And Risk Management Processes Fail

By Jon Speer, Med Device Online

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Thought Leadership Article

How design controls apply to a 510(k)

By Jon Speer, MedCity News

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Thought Leadership Article

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

Inspired Imua Podcast

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Thought Leadership Article

Why FMEA Is Not ISO 14971

By Jon Speer, Quality Digest

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Are Design Control Myths Holding Back Your Product Development?

By Jon Speer, Med Device Online

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

By Jon Speer, Medical Design Technology

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MedTech Blunders in Risk Management

By Jon Speer, MedTech Intelligence

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

By Jon Speer, MedCity News

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Risk: Look at the Big Picture

By Jon Speer, MedTech Intelligence

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How to Prepare for an FDA Inspection

By Jon Speer, Quality Digest

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6 Development Steps To Fast-Track Your Medical Device's Path To Market

By Jon Speer, Med Device Online

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Thought Leadership Article

The Design Controls + Risk Management Connection: Using Design Reviews Effectively

By Jon Speer, Med Device Online

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An alarming device trend: Why getting 510(k) clearance alone is not enough

By Jon Speer, MedCity News

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Thought Leadership Article

7 Steps to Respond to FDA 483 Inspection Observations

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

The Design Controls + Risk Management Connection â€” Verification, Validation & Risk Controls

By Jon Speer , Med Device Online

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Thought Leadership Article

The Importance of the Risk Management Plan

By Jon Speer, Medical Design Technology

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Design Controls & Risk Management: Two Sides of the Same Coin [Infographic]

By Jon Speer, MedCity News

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Risk Management: A Total Product Life-cycle Process [Infographic]

By Jon Speer, Legacy MEDSearch

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Risk Management for Medical Devices: An Introduction to the Process [Infographic]

By Jon Speer, MD+DI

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Risk management definitions you need to understand

By Jon Speer, Mass Device

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Thought Leadership Article

The beginner's guide to MedTech design verification and validation

By Jon Speer, MedCity News

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Thought Leadership Article

How to Avoid Exponentially Escalating Costs with Design Controls

By Jon Speer, MD+DI

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Thought Leadership Article

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

By Jon Speer, Medical Design Technology

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Thought Leadership Article

The Design Controls + Risk Management Connection â€” Intended Use & User Needs

By Jon Speer, Med Device Online

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Thought Leadership Article

5 tips to help you prepare for an FDA inspection

By Jon Speer, MedCity News

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Thought Leadership Article

4 Reasons Your Risk Management Approach is Wrong

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

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

By Nick Tippmann, Mass Device

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Thought Leadership Article

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

By Jon Speer, MedCity News

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5 Tips For Better Medical Device Risk Management

By Jon Speer, Med Device Online

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Thought Leadership Article

How to define medical device design inputs and outputs

By Jon Speer, MedCity News

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Thought Leadership Article

The Beginner's Guide to ISO 14971 Medical Device Risk Management

By Jon Speer, Medical Design Technology

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Thought Leadership Article

How medical device complaints can make you a better company

By Jon Speer, MedCity News

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Thought Leadership Article

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

By Jon Speer, OrthoStreams

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Ultimate Guide to Comparing Quality Management System Solutions