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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

8 Most Common Mistakes to Avoid with 21 CFR Part 820 - Featured Image

8 Most Common Mistakes to Avoid with 21 CFR Part 820

Medical device companies selling or planning to sell into the US market should be familiar with FDA'...
FDA QSIT: Preparing Your Medical Device Company for an Inspection - Featured Image

FDA QSIT: Preparing Your Medical Device Company for an Inspection

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...
5 Most Common Mistakes Made When Implementing ISO 14971 - Featured Image

5 Most Common Mistakes Made When Implementing ISO 14971

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...
The Essential Guide to Preparing your QMS for EU MDR - Featured Image

The Essential Guide to Preparing your QMS for EU MDR

How prepared is your quality management system for the new requirements of EU MDR for medical device...
Qualifying Your Suppliers Using a Risk-based Approach - Featured Image

Qualifying Your Suppliers Using a Risk-based Approach

This notion of risk-based processes within quality systems is something that has become part of our ...
How to Write Effective SOPs for Medical Devices - Featured Image

How to Write Effective SOPs for Medical Devices

Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...
8 Questions About the European MDR Answered - Featured Image

8 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
De Novo Pathway: Explaining the Process for Medical Device Companies - Featured Image

De Novo Pathway: Explaining the Process for Medical Device Companies

The De Novo pathway has been around for more than two decades, but it is still one of the least used...
Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories - Featured Image

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

  I'm thrilled to announce the officially launch of Greenlight Guru's second podcast series, MedTech...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

As medical device professionals, we share a common goal of producing safe and effective medical devi...
Abbreviated 510(k): Substantial Equivalence Through Performance Criteria - Featured Image

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...
Why Flexible Design Reviews Matter for Medical Device Product Development - Featured Image

Why Flexible Design Reviews Matter for Medical Device Product Development

It is my humble and expert opinion that the medical device industry has the most significant impact ...

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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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