Content
Which processing steps are required in a specific case? Which aspects must be taken into account during preparation validation? And does reprocessing validation really need to be carried out for all reusable medical devices?
Authorities and notified bodies are currently checking very intensively, also with regard to the EU MDR. It is therefore recommended to obtain information in good time in a very practice-oriented seminar: about legal requirements and current changes, reprocessing procedures and procedures, requirements for reprocessing instructions and hygienic product design, as well as validation strategies that are effective but at the same time reduce effort and are therefore also interesting for SMEs Advantages and disadvantages of the individual test methods.
Topic overview
- Objectives/basic requirements for processing
- Current status of standardization (including ISO 17664 3rd edition)
- Basics of preparation
- Process and objectives of effective preparation
- Standard-compliant reprocessing instructions according to EN ISO 17664 (3rd edition), new version AAMI TIR12 and FDA Reprocessing Guidance: 2015/2017
- Test program – proof of suitability for effective and repeated reprocessing (including FDA Reprocessing Guidance and ZLG RDS 007:2020)
- Hygienic design (as a basis for effective reprocessing)
- Summary/Discussion
target group
Manufacturers of medical devices that are intended for reprocessing and reuse or must be cleaned, disinfected and/or sterilized before initial use, as well as employees from development, product management, quality assurance, regulatory affairs and marketing.
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.
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