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

Quality Assurance vs. Quality Control in the Medical Device Industry

By Jon Speer on September 6, 2020

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

By Jon Speer on August 30, 2020

In the medical device industry, there’s a lot outside of our control. The market shifts. New, innova...

Meet a Guru: Wade Schroeder

By Nick Tippmann on August 19, 2020

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of m...

Unannounced Audits: A Survival Guide for Quality Managers

By Jon Speer on August 16, 2020

We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...

What are the Audit Etiquette Rules I Should be Following?

By Nick Tippmann on August 12, 2020

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself acco...

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...

Meet a Guru: Tom Rish

By Nick Tippmann on August 5, 2020

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge.

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...

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