FREE Resources

HELPING YOU Imagine, Introduce, and Advance better Medical Devices.

More than 34,000 rely on us for the latest in quality

eBooks and Guides

Ultimate Guide to FDA Design Controls for Medical Device Companies

How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

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

The Risk Management + Design Controls Connection

Everything device makers need to know about the Risk Management + Design Controls connection in medical device product development.

View all eBooks
Webinars

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

General Wellness Devices & Wearables: Regulatory Options You Need to Know

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

View All Webinars
Podcasts

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

Episode 62

Helping to Prepare Biomedical Engineers Entering the Workforce

Episode 61

How to Ensure Your Quality Management System is Effective and Benefits Patients

Episode 60

View All Podcasts
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 ...
View All Case Studies
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
View All Articles