How can medical device approval be achieved in a complex regulatory environment?
This central question was addressed in the EKFZ Academy Workshop “Medical Devices – Quality and Approval at a Glance” led by Dr. Sabine Hauck. Over two interactive hours, workshop participants explored the principles of medical device approval in the EU and the USA and familiarized themselves with the current regulatory environment. Drawing on her extensive expertise in the life science industry, Sabine Hauck also discussed the differences between medical devices and pharmaceuticals and provided practical tips for creating compliant documentation. Participants gained an initial overview of the regulatory framework for medical devices and learned that different approval pathways and quality systems apply to medical devices and pharmaceuticals.
We sincerely thank Sabine Hauck for this excellent and insightful workshop and the lively discussions!
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