Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

By Sara Adams on February 6, 2022

The European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Regulat...

Bill of Materials (BOM) for Medical Devices: Everything You Need To Know

By Laura Court on January 21, 2022

When it comes to complexity, medical devices run the gamut.

Understanding the Quality Control Process in Medical Device Manufacturing

By Taylor Brown on January 9, 2022

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

By Nick Tippmann on December 16, 2021

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

By Jesseca Lyons on December 12, 2021

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

By Etienne Nichols on December 5, 2021

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

By Tom Rish on November 28, 2021

The International Standardization Organization (ISO) is an independent, non-governmental organizatio...

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

By Jesseca Lyons on November 21, 2021

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

By Taylor Brown on November 14, 2021

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

By Etienne Nichols on November 12, 2021

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

By Taylor Brown on November 11, 2021

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

By Tom Rish on November 8, 2021

To ensure quality and mitigate the risk of subjectivity or bias, the European and Canadian medical d...

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