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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...
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?
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...
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. 
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...
COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health - Featured Image

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spr...
4 Major Reasons to Use Document Version Control Software for your Medical Device - Featured Image

4 Major Reasons to Use Document Version Control Software for your Medical Device

With the incredible volume of documentation required by the FDA and ISO, using a document control sy...
7 Tips to Attract Investors and Raise Funds for your Medical Device - Featured Image

7 Tips to Attract Investors and Raise Funds for your Medical Device

Is your medical device company in the midst of raising funds or planning to begin the process? There...
13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

As medical device professionals, we share a common goal of producing safe and effective medical devi...
3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...

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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