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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Document Management Training Management CAPA Management Audit Management Product Development

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Posts by Jon Speer

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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About the Author

Jon Speer is a medical device expert with over 20 years of 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.

Establishing a QMS

Qualifying Your Suppliers Using a Risk-based Approach

Jon Speer
May 19, 2019
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally... Read More
Product Development

How to Write Effective SOPs for Medical Devices

Jon Speer
May 12, 2019
Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, ISO and other regulatory bodies. How effective are your SOPs? Read More
MedTech Lifecycle Excellence

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

Jon Speer
April 7, 2019
{% video_player "embed_player" overrideable=False, type='scriptV4', hide_playlist=True, viral_sharing=False, embed_button=False, autoplay=False, hidden_controls=False,... Read More
Product Development

Why Document Control Matters To Medical Device Companies

Jon Speer
March 24, 2019
As medical device professionals, we share a common goal of producing safe and effective medical devices that meet all mandated compliance regulations and can be quickly... Read More
Product Development

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

Jon Speer
March 17, 2019
A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510(k) program. Establishing substantial equivalence through performance... Read More
Product Development

Why Flexible Design Reviews Matter for Medical Device Product Development

Jon Speer
March 10, 2019
It is my humble and expert opinion that the medical device industry has the most significant impact on improving the quality of life for all of humanity; more so than any... Read More
Regulatory Submission

What to Expect During an FDA QSIT Inspection

Jon Speer
February 17, 2019
You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are lucky, you may have been notified ahead of time that they’re coming, but... Read More
Product Development

5 Most Common Problems with your CAPA Process

Jon Speer
February 10, 2019
Year after year, the corrective and preventive action (CAPA) process continues to be the most widely shared challenge for most medical device companies. Read More
MedTech Lifecycle Excellence

Introducing The Greenlight Guru True Quality Roadshow 2019

Jon Speer
January 29, 2019
To the Medical Device Community, From the moment Greenlight Guru was founded, we have taken our leadership role of educating the industry on quality and regulatory changes... Read More

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