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Greenlight Guru Medical Device Blog

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

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

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 - Featured Image

Addressing Clinical Trial Challenges & Concerns during COVID-19

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? - Featured Image

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

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 - Featured Image

Protecting the Intellectual Property of your Medical Device Technology

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 - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...
Meet a Guru: Jesseca Lyons - Featured Image

Meet a Guru: Jesseca Lyons

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 - Featured Image

How to Escape the Lure of Legacy Quality Management Systems

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 - Featured Image

How to Build a QMS for a Medical Device

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 - Featured Image

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

Some companies in the medical device industry show resistance to digital technology, preferring to u...
Meet a Guru: Taylor Brown - Featured Image

Meet a Guru: Taylor Brown

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 - Featured Image

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

What is the expected process you should follow for your medical device design planning and controls?
What is Regulatory Due Diligence for Medical Devices? - Featured Image

What is Regulatory Due Diligence for Medical Devices?

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

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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