Fraunhofer Institute for Surface Engineering and Thin Films ISTWorkshop / May 10, 2022
Regulatory Forum of the High-Performance Center Medical and Pharmaceutical Engineering
The interactive workshop of the Fraunhofer High-Performance Center Medical and Pharmaceutical Engineering serves the exchange of information in the field of personalized medical devices. The focus lies on the interface between medical technology possibilities and regulatory framework conditions.
Personalized medical technology includes, for example, 3D manufacturing, point-of-care production, AI-supported personalized software and therapy-accompanying diagnostics.
As the original regulatory framework has changed, regulatory solutions for the different types of personalized medical devices are being sought on a global scale. Case studies will therefore be used to present and discuss the challenges and possible solutions for the placement of personalized medical devices on the market in the EU.
The second case study of the workshop comes from Dr. Kristina Lachmann and Prof. Dr. Michael Thomas:
12:55 - 13:10
”Coatings for medical devices - opportunities and benefits”
Afterwards, from 14:15-15:00, Dr. Kristina Lachmann will co-present with Anna Lena Weichaus at the round table on the topic of:
”Challenges and solutions for PMD and point-of-care manufacturing regulatory pathways”
The event will be held in German, a follow-up event in English is already being planned.