Time & location: June 2021, online on Zoom

Registration deadline: 17th of May 2021.

Outline of the course *:

Part 1 – Regulation and market acceptance
Lecturer:  Katharina von Struensee, Director Regulatory Affairs & Customer Compliance - CeramTec
9th of June 9:00  - 16:00 (CET)
• Regulatory affairs for medical devices
• Regulation and Market Entrance in the EU
• Regulation and Market Entrance in the US
• Excursus: Biological evaluation of Medical Devices
+ Group work

Part 2 –Standards for use in the medical engineering industry
Lecturer: Bryan McEntire, SINTX
14th of June 16:00  - 18:00 (CET) & 17th of June 16:00  - 18:00 (CET)
• Lecture: ISO 13485:2016 “Medical devices - Quality management systems -Requirements for regulatory purposes”, 21 CFR 820. “FDA Quality Systems Regulations,” and ISO 10993:2018 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.”
+ Group work

Part 3 - Measurement and analysis in testing
Lecturer: Bryan McEntire, Chief Scientific Officer, SINTX
21th of June 16:00  - 18:00 (CET) & 24th of June 16:00  - 18:00 (CET)
• Lecture, important standards for ceramic materials (e.g., ISO 6474-1:2019, ISO 6474-2:2019, along with several of the detailed testing standards (i.e., chemical analysis, physical and mechanical properties, etc.).
+ Group work

Part 4 - Testing industry – design and validation of advanced testing equipment
Lecturer: Markus Flohr, Head of Testing, CeramTec
28th of June 9:00  - 16:00 (CET)
• Evaluation of load application (e.g. for FE simulation)
• Development of test set-up  representing application
• Validation of test set up using various methods (strain gages, tolerance analysis, MSA, etc.)
+ Group work

 *4 ECTS credits in case if all lectures are attended and all home assignments are fulfilled