Not only the selection of materials, but also the processing, packaging, and reprocessing of medical devices pose major challenges for medical device developers and manufacturers. In this practice-oriented in-house training, you will receive all relevant information needed to meet the regulatory requirements of ISO 10993 and the U.S. standard USP.
Seminar contents
Morning: Biocompatibility according to ISO 10993 / USP:
- Regulatory background
- Focus areas of ISO 10993:
– Clinical evaluation according to MEDDEV / MDR
– Assessment and testing within a risk management system
– In vitro and in vivo testing according to ISO 10993
- Focus areas of the USP*:
Medical devices
Biocompatibility
In vitro and in vivo testing according to USP*
*USP: The biocompatibility of medical devices is regulated in the United States by the U.S. Pharmacopeia (USP).
Afternoon: Topics to choose from:
- cleaning validation
- stability during storage
- Extractable & Leachables,
- Selection of materials
- Reprocessing of medical devices
Costs
1 day in-house training: EUR 3.890 (excluding VAT) for up to 10 participants
including seminar materials and certificate of attendance, plus travel expenses
Your trainer
DI Gabriele Ettenberger, long-standing expert in material applications and material testing for pharmaceuticals, medical devices, and hygiene, with 25 years of experience in the development and testing of medical devices at OFI, Vienna. Provides consulting and support for national and international medical device manufacturers in the areas of biocompatibility, cleaning validation, storage stability, extractables & leachables, risk assessments, material selection, and reprocessing of medical devices. Offers in-house training sessions and innovation workshops, is a certified adult education trainer, and provides mentoring.
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
