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eBooks and Guides

THE ULTIMATE GUIDE TO MEDICAL DEVICE CAPA

Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.

Definitive Guide to ISO 14971 Risk Management

Learn what is expected from regulators & how you can start to use risk management as a tool - not a checkbox activity.

Guide to Design Verification and Design Validation

Learn exactly what design verification and design validation are, how they are the same, how they are different, and best practices for medical devices.

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Webinars

How To Prepare for the Transition to ISO 13485:2016

Understanding the Changes to ISO 13485:2016

An Overview of ISO 14971 Risk Management

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Podcasts

Lessons to Be Learned From Recent FDA Inspections

Episode 51

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

Episode 50

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

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Case Studies

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

In today’s episode we continue our series on new breed medical device company stories.

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

Zebra Medical Technologies is part of a new breed of medical device companies.

Recovery Force Accelerates Their Product Development Efforts Using greenlight.guru

With its innovative technology in the highly competitive and expanding compression therapy market ...
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In The News
Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'

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

By John Speer

Medical Device and Diagnostic Industry April 25th, 2017

4 key compliance issues for medical device companies

4 key compliance issues for medical device companies

By Jon Speer

MedCity News April 13th, 2017

Five Tips for Medical Device Engineers on FDA Design Controls

Five Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer
Quality Digest March 28th, 2017
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