Dr. Johannes Goldmann

Why you should consider clinical studies in Australia

By Dr. Johannes Goldmann June 28, 2024 Leave a comment

Conducting clinical studies in Australia is not on the radar of many medical device manufacturers. However, good reasons exist to consider this continent for clinical studies or investigations. Yet manufacturers should also be aware of Australia’s regulatory requirements and specific disadvantages. 1. Advantages and disadvantages of clinical studies in Australia 1.1 Advantages of clinical studies…

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PMCF studies: three types to be distinguished

By Dr. Johannes Goldmann July 18, 2023 Leave a comment

PMCF studies are studies that manufacturers use as part of Post-Market Clinical Follow-up (PMCF) to continuously demonstrate compliance of their medical devices. Manufacturers do not always need to conduct studies to meet PMCF requirements. And not all types of PMCF studies are subject to MDR requirements. This article compactly summarizes the regulatory requirements in the…

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