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In order to be able to provide information on biocompatibility, many questions must be answered:
What does the surface of your medical device look like?
How do your production processes affect the surface?
What auxiliary and operating materials do you use?
Which ones become part of the interface and can no longer be removed?
Which starting materials are toxicologically questionable (CMR substances), but the products are not?
How must the process parameters be or be monitored?
topic overview
- Raw materials, auxiliary and operating materials
- Reactions in the production process including process parameters and toxicity
- Estimation of the type and quantity of toxicologically questionable material components that are produced
- Process validation and monitoring (risk-based approach)
- Analytical possibilities for characterizing the surface
- Cleaning processes that are specially tailored to the contamination to be expected
- Laser marking and packaging
target group
All employees in medical technology in production, quality management and/or development.
previous knowledge
Not mandatory.
KONTAKT:
Online
