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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 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?
Driving Medtech Innovation with Safe and Effective Medical Devices - Featured Image

Driving Medtech Innovation with Safe and Effective Medical Devices

In the medical device industry, innovation is a complicated subject.
Understanding Intended Use from ISO TR 24971:2020 - Featured Image

Understanding Intended Use from ISO TR 24971:2020

If you haven’t yet got into ISO TIR 24971:2020, there’s a fair bit to read up on.
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Would things be simpler in the medical device regulatory space if there was global harmonization acr...
Top Risk Management Tools in the Medical Device Industry - Featured Image

Top Risk Management Tools in the Medical Device Industry

The role of risk management for medical devices is not just a regulatory expectation, it’s a critica...
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.

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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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