target group
Manufacturers of reusable surgical instruments, future responsible persons, QM employees.
content
Reusable surgical instruments are assigned to risk class Ir according to the EU-MDR. This means that the manufacturers of these products are faced with comprehensive requirements for the conformity assessment, which must be implemented by May 26th, 2024. From this date, newly produced surgical instruments must have a CE certificate from a Notified Body before they can be placed on the market. In most cases, this in turn requires a certified QM system, which was previously not necessary for Class I products in this form - and the new MedicalMountains compact course provides targeted, pragmatic support for this. The compact course conveys the specifications for an appropriate quality management system and the structure of technical product documentation appropriate to the risk. Great importance is attached to the implementation of the new EU-MDR requirements through practical exercises and examples on existing templates, with the aim that the participants can implement this directly in the company.
Topic overview & dates
11/21/2022 Requirements of the EU-MDR related to Ir products | Structuring of the product range and division into product groups
11/22/2022 The EU-MDR compliant quality management system
11/23/2022 Content and structure of the technical documentation for Ir products | Risk management and clinical evaluation
11/24/2022 Evaluation and proof of hygienic and functional safety after reprocessing | Instructions for use and labeling
25.11.2022 Market surveillance, vigilance procedures and registration requirements | Test
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. After passing the exam, the participant receives a certificate issued by MedicalMountains GmbH.
a notice
Basic knowledge of quality management and technical product documentation is advantageous.
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen
