Content
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 retained samples no longer sufficient to prove the tightness of the packaging?
In this practice-oriented basic seminar, participants receive a complete overview of everything that needs to be taken into account when it comes to 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 - which is why it is very important to know the relevant requirements and implement them in a goal-oriented manner. This is exactly where the seminar supports the participants, who can implement what they have learned and what they have learned in their everyday work with medical products that are delivered sterile.
Topic overview
- Basic requirements from MDD to EU-MDR
- Product development/risk management
- Production hygiene/monitoring
- Product purity/cleaning (including DIN TS 5343 and future ISO 8250)
- Sterilization packaging (including new version of DIN EN ISO 11607-1/2)
- sterilization
- Biological compatibility (including new versions of ISO 10993-1, -12 and -18)
- Process qualification/technical documentation
- Process and product release
- Summary/Discussion
target group
Newcomers to medical technology as well as manufacturers of medical products delivered sterile, employees from development, product management, production, quality assurance and regulatory affairs, as well as in collaboration with development, production, packaging, final cleaning and/or sterilization service providers.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen
