The Medical Devices Implementation Act regulates the circulation of medical devices in Germany. Its main objectives are to ensure the safety, suitability, and performance of the products. It aims to protect patients, users, and third parties.
The seminar contents
- Purpose, scope, and definitions
- Notification requirements, placing on the market, and commissioning of products
- Vigilance and surveillance
- Medical device consultant
- Competent authorities for medical devices in Germany
- Criminal and administrative penalty provisions
- Transitional provisions
Note: The following chapters will not be covered in detail; if needed, the duration of the seminar would have to be extended by half a day: notified bodies, testing laboratories, …; clinical investigations, performance studies, …; special regulations for the area of the German Armed Forces, …
Costs
1/2 day in-house training: EUR 1.945 (excluding VAT) for up to 10 participants, including seminar materials and certificates of attendance, plus travel expenses
Individual training sessions (extended duration): Prices available upon 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.
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
