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What requirements do sterile medical devices actually have to meet? Do I always have to produce these in a clean room or are there other options? And why is a sterility test of reserve samples no longer sufficient to prove the tightness of the packaging? In this practice-oriented basic seminar, the participants receive a complete overview of everything to be considered for sterile medical devices, as well as insights into particularly important aspects.
Notified bodies and authorities check very intensively, especially with regard to the EU-MDR - therefore it is very important to know the relevant requirements and to implement them in a goal-oriented manner. This is exactly where the seminar supports the participants, who can easily implement what they have worked out and learned in their everyday work with medical devices that are delivered sterile.
The speaker is an expert in biological safety, has been supporting medical device manufacturers in Germany and abroad for almost 30 years and has been an expert at DIN and ISO on sterilization processes for more than 20 years.
topic overview
- Basic requirements from MDD to MDR
- Product development / risk management
- Production hygiene / monitoring
- Product purity / cleaning (including new DIN TS 5343)
- Sterilization packaging (including new version of DIN EN ISO 11607-1/2)
- sterilization
- Biocompatibility (including revised ISO 10993-1, -12 and -18)
- Process qualification / technical documentation
- Process and product release
- Summary / Discussion
target group
Newcomers to medical technology and manufacturers of medical devices that are delivered sterile, employees from development, product management, production, quality assurance and regulatory affairs, as well as in cooperation with development, production, packaging, final cleaning and/or sterilization service providers.
previous knowledge
Not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen
