Medical Devices Operator Ordinance, EN 62353 and ÖVE/ÖNORM E 8701-1
The Medical Devices Operator Ordinance is a regulation under the Medical Devices Act. It governs the incoming inspection, maintenance, recurrent testing, calibration, intervals, and user training for medical devices.
In this seminar, our expert DI Andreas Parzer will explain how you can efficiently implement the requirements of the ordinance.
The seminar contents
- Relevant terms from the Medical Devices Act (MPG) and the EU Medical Device Regulation (MDR)
- Incoming inspection
- Suitability for inspections (who is authorized to conduct inspections?)
- Periodic inspection
- Metrological checks
- inspection intervals
- device file, inventory list and implant register
- standards for testing after repair and modification of medical electrical equipment and medical laboratory equipment
Costs
Standard in-house training: Euro 3,890 (excl. VAT) for 1 day with up to 10 participants, including seminar materials and certificate of participation, plus travel expenses.
Individual training sessions: Prices on request.
your trainer
DI Andreas Parzer, over 25 years of technical management of the accredited testing laboratory at TÜV AUSTRIA for medical electrical equipment and medical laboratory devices, lead auditor for the quality management standards EN ISO 9001 and EN ISO 13485, and auditor for 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
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
