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Greenlight Guru Medical Device Blog

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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...
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...
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...
Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief - Featured Image

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focu...
How Being Strategic During A Career Transition Can Yield The Best Opportunities - Featured Image

How Being Strategic During A Career Transition Can Yield The Best Opportunities

There is a spectrum of feelings someone may experience in the midst of a career transition. For some...
Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry - Featured Image

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

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...
How to Construct an Effective Regulatory Strategy - Featured Image

How to Construct an Effective Regulatory Strategy

What is a regulatory strategy? What are the components involved?
What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD) - Featured Image

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...
How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices - Featured Image

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

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...
510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies - Featured Image

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

What does the 510(k) process involve? How should medical device companies know if this is the right ...
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers - Featured Image

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for fr...
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem - Featured Image

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

What impact will the EU MDR changes have on the medical device ecosystem?

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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