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Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered - Featured Image

Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered

There are plenty of new requirements to be aware of in both the EU Medical Device Regulation (EU MDR...
Engineering Change Order: The Role it Plays in the Change Management Process - Featured Image

Engineering Change Order: The Role it Plays in the Change Management Process

Change is just part of life for medical device companies. No device makes it to market without quite...
How to Approach Corrective Action Requests with Medical Device Suppliers - Featured Image

How to Approach Corrective Action Requests with Medical Device Suppliers

For medical device manufacturers, finding success means setting ourselves up for success with repeat...
The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers - Featured Image

The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers

The internet of things (IoT) is a blanket term used to describe the billions of connected objects an...
3 Non-negotiables for Managing Business Risk as a Medical Device Company - Featured Image

3 Non-negotiables for Managing Business Risk as a Medical Device Company

How seriously do you take risk management? This may seem like an inane question, especially for a pr...
Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry - Featured Image

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry

To ensure quality and mitigate the risk of subjectivity or bias, the European and Canadian medical d...
IEC 62366 Explained: What You Need To Know About Usability Engineering - Featured Image

IEC 62366 Explained: What You Need To Know About Usability Engineering

Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on desi...
Ultimate Guide to QA & RA in Medical Device 3D Printing - Featured Image

Ultimate Guide to QA & RA in Medical Device 3D Printing

This document aims to guide users in the medical device industry through every stage of the product ...
Software as a Medical Device: Definitions, Examples & Regulatory Framework - Featured Image

Software as a Medical Device: Definitions, Examples & Regulatory Framework

Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of ta...
3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
Creating a Quality Manual That Complies with ISO 13485 - Featured Image

Creating a Quality Manual That Complies with ISO 13485

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...
Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile - Featured Image

Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical d...

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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