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Understanding the Quality Control Process in Medical Device Manufacturing - Featured Image

Understanding the Quality Control Process in Medical Device Manufacturing

The goal of any medical device is to improve the lives of its users.
Customers Rank Greenlight Guru As Leading QMS Software on G2 For 13th Consecutive Quarter - Featured Image

Customers Rank Greenlight Guru As Leading QMS Software on G2 For 13th Consecutive Quarter

Greenlight Guru is proud to announce that it has been selected - by users - as the leading QMS for t...
IQ, OQ, PQ: A Quick Guide to Process Validation - Featured Image

IQ, OQ, PQ: A Quick Guide to Process Validation

In the medical device industry, even one failure in a process can lead to devastating consequences f...
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...
Ultimate List of ISO Standards for Medical Devices - Featured Image

Ultimate List of ISO Standards for Medical Devices

The International Standardization Organization (ISO) is an independent, non-governmental organizatio...
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...
Failure Mode Effects Analysis: What Is It & When Should You Use It? - Featured Image

Failure Mode Effects Analysis: What Is It & When Should You Use It?

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...
What’s the Difference Between Clinical Evaluation and Clinical Investigation? - Featured Image

What’s the Difference Between Clinical Evaluation and Clinical Investigation?

Within the myriad of regulations and standards governing medical devices, there are a number of simi...

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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