Australia and New Zealand are often target countries for MedTech companies looking to expand into a new market ..read more

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

FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs ..read more

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

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 methods for the clinical study they want to carry out. It’s meant to be a comprehensive and detailed manual for the investigators, ethics committee, and competent authorities who will review the proposed study before it can begin ..read more

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 surgery devices.  ..read more

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations ..read more

In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group ..read more

The regulatory pathway for getting a Class III medical device to market in the US is known as Premarket Approval (PMA). Given that Class III devices pose the highest risk to patient safety, the PMA process is lengthy and requires a large amount of information about the device and the data backing up its safety and effectiveness claims.  ..read more

In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry ..read more