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

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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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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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MedTech Lifecycle Excellence

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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Product Development

Machine Learning, AI and Risk Management: TIR34971 Explained

Etienne Nichols
August 18, 2023
TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. Read More
MedTech Lifecycle Excellence

Regulatory Strategy and the Advantage of Diversity in MedTech

Etienne Nichols
August 17, 2023
In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Read More
Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

Chris Rush
August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
MedTech Lifecycle Excellence

Greenlight Guru Invests in State-of-the-Art Arena and Training Facility That Aims to Help Youth Basketball Players On and Off the Court

Jeff Perkins
August 15, 2023
The software company is making a significant charitable investment to improve the quality of life for young athletes. Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

Etienne Nichols
August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
MedTech Lifecycle Excellence

28 Days To Save The World - True Quality Roadshow

Etienne Nichols
August 10, 2023
During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

Naomi Schwartz
August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
MedTech Lifecycle Excellence

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

Etienne Nichols
August 3, 2023
In today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. Read More
MedTech Lifecycle Excellence

The Right Way to Start a QMS: When, How, & What

Etienne Nichols
July 28, 2023
Most people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start,... Read More

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