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MedTech Lifecycle Excellence

FDA's Voluntary Improvement Program

March 21, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss... Read More
MedTech Lifecycle Excellence

The State of UDI Across the World

March 7, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and... Read More
MedTech Lifecycle Excellence

Adopting AI in Quality Management: Practical Solutions for the MedTech Industry

March 5, 2024
In MedTech, an increasing number of companies are introducing devices integrated with AI technologies. Read More
Clinical Data Collection

Outsourcing Clinical Activities in 2024: Choosing A CRO

March 4, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, 70% of respondents told us they were going to outsource at least some of their clinical activities to a... Read More
Establishing a QMS

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

February 26, 2024
One consequence of the massive growth of software as a medical device (SaMD) and software in a medical device (SiMD) is the growing overlap between the realms of software... Read More
MedTech Lifecycle Excellence

Quality Myths & Lessons Learned Part II

February 22, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. Read More
Establishing a QMS

How MHRA is Regulating Medical Devices in the UK after Brexit

February 22, 2024
If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in the regulatory landscape resulting from Brexit are relevant to you. Read More
Post-Market Surveillance

Investigator Initiated Studies — 3 Common Problems and How to Fix Them

February 22, 2024
An investigator initiated study (IIS) is a clinical trial of a device that is sponsored by an independent researcher, rather than the manufacturer of the device. The clinical... Read More
Establishing a QMS

5 Habits of Highly Effective MedTech Companies

February 20, 2024
At Greenlight Guru, our annual State of the MedTech Industry Report offers a comprehensive view of our industry and the opinions and outlook of more than 500 MedTech... Read More

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