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Greenlight Guru Medical Device Blog

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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...
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?
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...
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

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

When your medical device product development project gets to Design Verification and Design Validati...
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...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? - Featured Image

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

The medical device industry has a lot of acronyms. 
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?
22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles - Featured Image

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device qua...
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...
EUA 101: What is Emergency Use Authorization and How can my Device get Authorized? - Featured Image

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

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 - 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 ...

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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