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Greenlight Guru Medical Device Blog

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Jon Speer

Jon Speer
Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Author's Posts

How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...
3 Valuable Outcomes of a Culture of Quality - Featured Image

3 Valuable Outcomes of a Culture of Quality

Do you consider your medical device company to have a culture of quality?
Why a Visual QMS is So Important for Your Medical Device Company - Featured Image

Why a Visual QMS is So Important for Your Medical Device Company

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...
How Does a Medical Device Quality Management System Differ from other QMS Tools? - Featured Image

How Does a Medical Device Quality Management System Differ from other QMS Tools?

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...
Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means - Featured Image

Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means

Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “sub...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

In an industry that is ever-evolving, change is inevitable.
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
6 Benefits of the Best 21 CFR Part 11 Compliant Software - Featured Image

6 Benefits of the Best 21 CFR Part 11 Compliant Software

Nearly every medical device company is subject to software validation requirements, regardless of wh...
12 Medical Device Experts Offer Best Tips for How to Succeed in 2021 - Featured Image

12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

How will COVID-19, new regulatory programs and changes, and technological advancements impact your m...
Free Complaint Template for Medical Devices - Featured Image

Free Complaint Template for Medical Devices

One of the major post-market responsibilities of medical device companies is handling customer compl...
Free Template: Nonconformance Process for your Medical Device - Featured Image

Free Template: Nonconformance Process for your Medical Device

Eventually, every quality professional is going to have to deal with nonconformance. In the medical ...
A Free CAPA Template for the Medical Device Industry - Featured Image

A Free CAPA Template for the Medical Device Industry

If you’re a medical device professional, you’ve likely heard the acronym “CAPA” before. For those wh...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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