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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
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

FDA Issues LDT Final Rule to Regulate Laboratory Developed Tests as IVD Devices

April 30, 2024
FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs). 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
Clinical Data Collection

MDCG 2024-3: What the Latest Guidance on Clinical Investigation Plans (CIP) Tells Us

April 30, 2024
A clinical investigation plan (CIP) is the document in which the investigation’s sponsor will lay out the rationale, objectives, design, conduct, record-keeping and analysis... Read More
MedTech Lifecycle Excellence

Bringing a Self-Funded Medical Device to Market

April 25, 2024
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow... Read More

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