The installation, maintenance, and regular testing of medical devices are key prerequisites for patient safety and compliance with legal requirements. In this in-house seminar, you will receive a practical overview of the most important requirements and learn how to implement them safely and efficiently.
For the maintenance, installation, and testing of medical devices, the provisions of Regulation (EU) 2017/745, the Medical Devices Act (MPG) 2021, the Medical Device Operator Ordinance, and the applicable standards must be taken into account.
The manufacturer’s specifications are of great importance. A draft version of the Medical Device Operator Ordinance from 2025 is available, which is intended to replace the currently applicable version from 2007.
- Regulation (EU) 2017/745, Medical Devices Act (MPG) 2021, Medical Device Operator Ordinance (MPBV)Seminar Contents*
- Medical Devices Act 2021
- Medical Device Operator Ordinance
- ÖVE / ÖNORM EN 62353 – Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment
* each referring to participants involved in maintenance, testing, and installation
- Basic course (beginners) or seminar (advanced)
- Persons who carry out repairs, maintenance, installations, or testing of medical devices.
- Basic knowledge of the Medical Devices Regulation and the Medical Devices Act would be beneficial, but the seminar can also be booked as a basic course.
Your trainer, DI Andreas Parzer, has over 25 years of experience as the technical head of the accredited testing laboratory at TÜV AUSTRIA for medical electrical equipment and medical laboratory devices. He is a lead auditor for the quality management standards EN ISO 9001 and EN ISO 13485, and an auditor for the Medical Devices Directive (MDD). Trainer for many years at en.co.tec medical technology seminars and en.co.etc in-house training courses, at the WIFI St. Pölten and at the TÜV Austria Academy for the standards EN 60601-1, EN 60601-1-x, EN 60601-2-x and EN 80601-2-x. Trainer for in-house training courses on standards for medical electrical devices and QM systems for medical devices. Member of the OVE Technical Standards Committee for Medical Devices and the international working group IEC SC62A / WG 14, which deals with the IEC 60601-1 standard.
Information about our trainers Costs: Standard in-house training: €3.890 (excluding VAT) for 1 day with up to 10 participants, including seminar materials and certificate of participation, plus travel expenses.
Customized training sessions: Prices available on request.
Book now: Please send your inquiry to: seminare@encotec.ator call us: +43 1 8863491
