Medical Device Quality, Regulatory and Product Development Blog

How Do I Determine if my Product is a Medical Device?

By Jon Speer on August 2, 2020

Let’s say you’re in the medical industry but not yet in the medical device industry. You’re working ...

Addressing Clinical Trial Challenges & Concerns during COVID-19

By Nick Tippmann on July 29, 2020

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst...

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...

Protecting the Intellectual Property of your Medical Device Technology

By Nick Tippmann on July 22, 2020

Should you have patent protection for your medical device technology? Should you keep your secret sa...

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...

Meet a Guru: Jesseca Lyons

By Nick Tippmann on July 15, 2020

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with...

How to Escape the Lure of Legacy Quality Management Systems

By Jon Speer on July 12, 2020

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...

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...

Meet a Guru: Taylor Brown

By Nick Tippmann on July 1, 2020

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over e...

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...

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