In our new podcast Dr. Andreas Grund talks to expert Dr. Andreas Beust about Sponsorship as a Service. What is sponsorship as a service? For which companies is it the best option? How are competent authorities and ethics committees reacting to it?

Join us on the GCP Mindset channel for an insightful video on In Vitro Diagnostics Regulations (IVDR). Dr. Alexandra Ortiz Rodriguez, our expert guest, will cover everything you need to know. Discover the classifications in the USA and Europe, explore the differences in regulations, and learn about the significance of EUDAMED, the European database for medical devices. Gain valuable insights into the limitations of IVDR implementation, the role of notified bodies, and the importance of performance evaluation. Don’t miss out on this engaging discussion!

In this informative podcast on the GCP Mindset channel, expert Martin Schäfer discusses the topic of post-market clinical follow-up (PMCF) studies. As medical technology advances, it’s becoming increasingly important to test products in everyday use to identify any safety concerns that were not detected during pre-market testing. Schäfer explains the different types of PMCF studies and their regulatory requirements, including the challenges of navigating different national regulations. He also offers valuable advice for planning a PMCF study, such as being realistic about timelines and seeking advice to ensure compliance with ethical and regulatory standards. This is a must-watch video for anyone involved in the medical device industry.

What is modern Quality Assurance, what is Quality Control and what has it to do with our Audits, Findings and Quality Management? What do we have to keep in mind for better and effective Quality Assurance?
Find the answers and more in our interview with Dr. Andreas Grund and expert Petra Štěpánková.

In times of the Corona Pandemic clinical trials are a challenge. What do we have to consider, what are the regulatory aspects? What advices do we get from the FDA and EMA? Find some answers given by Dr. Andreas Grund.