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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?
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 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...
Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS - Featured Image

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

As medical device companies around the globe are continuing to operate among the implications of COV...
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. 
[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?
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...
How to Approach Verification and Validation for Cloud Software - Featured Image

How to Approach Verification and Validation for Cloud Software

Why is verification and validation (V&V) confusing and challenging for many medical device professio...
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...
How to Integrate Usability into your Medical Device - Featured Image

How to Integrate Usability into your Medical Device

Medical device usability is a critical, yet confusing component of medical device design, developmen...
[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD) - Featured Image

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

In this modern digital world, did you know that most medical devices are not connected to the Intern...

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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