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Greenlight Guru Medical Device Blog

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Challenges related to Home Use Devices - Featured Image

Challenges related to Home Use Devices

What could go wrong as more medical device products are used at home and in similar non-traditional ...
Quality Assurance vs. Quality Control in the Medical Device Industry - Featured Image

Quality Assurance vs. Quality Control in the Medical Device Industry

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...
Submitting a 510(k) using FDA's Safety and Performance Based Pathway - Featured Image

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...
Document Control for Medical Device Companies: The Ultimate Guide - Featured Image

Document Control for Medical Device Companies: The Ultimate Guide

According to the original data findings of our 2020 State of Medical Device Product Development and ...
5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

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

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