MedicalMountains GmbH

Service Provider

MedicalMountains GmbH Reprocessing of medical devices — EN ISO 17664 (3rd edition), RDS 007, FDA

28.09.2023 - 28.09.2023 | Seminars

content

Which processing steps are required in the specific case? Which aspects have to be considered in a processing validation? And does reprocessing validation really have to be carried out for all reusable medical devices? Authorities, but also notified bodies, are currently checking very intensively, also with regard to the EU-MDR. Therefore, it is recommended to find out about timely information in a very practice-oriented seminar: about legal requirements and current changes, processing procedures and processes, requirements for the processing instructions and hygienic product design as well as about target-oriented, but at the same time cost-reducing and therefore also interesting validation strategies for SMEs, as well Advantages and disadvantages of the individual test methods.

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, ISO and ZLG on sterilization and preparation processes for more than 20 years.

topic overview

Objectives / basic requirements for processing
Current status of standardization (including ISO 17664 3rd edition)
Basics of processing
Process and objectives of an effective treatment
Standard-compliant reprocessing instructions according to EN ISO 17664 (3rd edition), new version AAMI TIR12 and FDA Reprocessing Guidance
Test program - proof of suitability for effective and repeated processing (including FDA Reprocessing Guidance and ZLG RDS 007:2020)
Hygienic design (as the basis for effective treatment)
Summary / Discussion

target group

Manufacturers of medical devices that are intended for reprocessing and reuse or that have to be cleaned, disinfected and/or sterilized before they are used for the first time, as well as employees from development, product management, quality assurance, regulatory affairs and marketing.

previous knowledge

Knowledge of the basic requirements for medical devices is helpful.