Medical Device Quality, Regulatory and Product Development Blog

Design History File Ready Ideation: An Innovative Approach to Product Development

By Nick Tippmann on July 3, 2019

As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)?

Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)

By Jesseca Lyons on June 30, 2019

I hate Risk Management. There, I said it. And I’m not the only one actually. We’re all thinking it. ...

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

By Nick Tippmann on June 26, 2019

The FDA recently decided to discontinue its alternative summary reporting program due to the allegat...

8 Most Common Mistakes to Avoid with 21 CFR Part 820

By Jon Speer on June 23, 2019

Medical device companies selling or planning to sell into the US market should be familiar with FDA'...

Creating a Culture of Quality for Medical Device Companies

By Nick Tippmann on June 21, 2019

Is creating a culture of quality a top priority at your MedTech company? But you’re not sure how or ...

Challenges with MedTech Innovation

By Nick Tippmann on June 19, 2019

The medical device industry strives to develop high quality and innovative products that will contri...

FDA QSIT: Preparing Your Medical Device Company for an Inspection

By Jon Speer on June 17, 2019

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...

Is Your Medical Device Company CAPA Happy?

By Nick Tippmann on June 12, 2019

The medical device industry could be more proactive than reactive when managing systemic issues. We’...

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

By QRA Corp on June 9, 2019

We distilled the insights from our research into this one guide + checklist that we hope will help a...

Integrating Human Factors into Design Controls to Improve Patient Outcomes

By Nick Tippmann on June 5, 2019

The relationship between human factors and design controls often creates confusion in the medical de...

5 Most Common Mistakes Made When Implementing ISO 14971

By Jon Speer on June 2, 2019

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...

Greenlight Guru In the Classroom: A University's Real-world Approach

By Nick Tippmann on May 29, 2019

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...

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