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MedTech Lifecycle Excellence

Interviewing the Interviewer

May 23, 2024
In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable... Read More
Product Development

Beginner's Guide to Design Verification & Design Validation for Medical Devices

May 22, 2024
Design verification and design validation are two essential stages in design controls. It’s easy to confuse the two because they both involve checking an outcome against your... Read More
Regulatory Submission

Ultimate Guide to Device Class Requirements under EU MDR

May 22, 2024
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
MedTech Lifecycle Excellence

Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List

May 9, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five... Read More
MedTech Lifecycle Excellence

Entering the Australia & New Zealand Markets: What Medical Device Manufacturers Need to Know

May 8, 2024
Australia and New Zealand are often target countries for MedTech companies looking to expand into a new market. Read More
Product Development

QMS Principles for Software As a Medical Device (SaMD) Manufacturers

May 6, 2024
Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and many companies with software development capabilities are branching out... Read More
MedTech Lifecycle Excellence

Medical Device Reporting: The Do's and Don'ts

May 2, 2024
In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). Read More
Product Development

How are Medical Devices Classified under EU MDR?

May 1, 2024
One of the most important steps in bringing a medical device to market in the European Union (EU) is determining the correct classification for your device. Read More
MedTech Lifecycle Excellence

Building a Partnership with your Regulatory Consultant

April 30, 2024
In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. Read More

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