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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
MedTech Lifecycle Excellence

Mastering the Pitch: MedTech Innovations from Concept to Market

February 20, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Read More
MedTech Lifecycle Excellence

How to Use the Turtle Diagram for Better Internal Audits

February 9, 2024
An internal audit can be an overwhelming prospect, especially if you’re new to the company or internal auditing in general. Read More
MedTech Lifecycle Excellence

Greenlight Guru Announces the 2024 True Quality Roadshow

February 9, 2024
The free MedTech event series will make stops in four cities, including an international event in Europe. Read More
MedTech Lifecycle Excellence

Becoming a MedTech Regulatory Affairs Professional

February 7, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory... Read More

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