Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

By The RND Group on July 26, 2020

The FDA has released a discussion guideline and request for feedback regarding changes in the certif...

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

By Jon Speer on July 5, 2020

Some companies in the medical device industry show resistance to digital technology, preferring to u...

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

By Jon Speer on June 28, 2020

What is the expected process you should follow for your medical device design planning and controls?

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...

How to Validate Cloud-based Software Tools

By The RND Group on June 21, 2020

Do you remember what computing tools you were using in 2002? I would guess, if you were old enough t...

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

By Jesseca Lyons on June 12, 2020

When your medical device product development project gets to Design Verification and Design Validati...

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

By Jesseca Lyons on May 29, 2020

The medical device industry has a lot of acronyms.

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020

What is a regulatory strategy? What are the components involved?

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

By Jon Speer on May 17, 2020

On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

By Nick Tippmann on May 13, 2020

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...

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