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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...
Design Validation vs. Human Factors Validation - Featured Image

Design Validation vs. Human Factors Validation

  Human factors and risk create a lot of confusion in the medical device industry. What do you need ...
Why Your Company Needs an Electronic Quality Management System - Featured Image

Why Your Company Needs an Electronic Quality Management System

It’s time to face facts: a paper-based quality management system is no longer an option. 
Understanding the 5 Phases of Medical Device Development - Featured Image

Understanding the 5 Phases of Medical Device Development

Do you have a medical device to launch? Well I have good news for you and I have bad news for you.
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

Design Validation vs. Clinical Evaluation: What’s the Difference?

How confident are you when it comes to design validation? Does this always involve clinical evaluati...
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...

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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