Online-Seminar Medical Device Advisor Training according to § 83 MPDG
Gain essential knowledge for Medical Device Advisors (MDAs) in this online training. Learn legal frameworks, responsibilities, and compliance requirements according to MDR and MPDG. Understand market access, classification, labeling, and compliance behavior. Essential for MDA roles.
12.09.2024 09:00 - 15:00 Uhr
organizer: BVMed-Akademie
Schwerpunkt: Recht
Zum Thema
In order to work as a medical device advisor (MDA) and inform healthcare professionals about or instruct them in the proper handling of medical devices, it is necessary to have and be able to demonstrate the necessary expertise, see § 83 MPDG. The training provides the necessary basic knowledge independent of the product and company. This includes the presentation of the rights, tasks and duties of the MDA, in each case based on the legal requirements resulting in particular from the MDR and the MPDG.
The European and national legal frameworks that apply to medical devices are explained. Participants will learn about several requirements like placing medical devices on the market, the classification and labeling of a medical device or market surveillance and vigilance activites. Furthermore, knowledge of operator law and compliance-compliant behavior in the event of feedback from the market are part of this seminar. A comprehensive understanding of all of the above is essential for adhering to the obligations and requirements of the MDA.
Zielgruppe
The seminar is intended for all employees of medical device manufacturers and other economic operators (e.g. distributors) who provide technical information about medical devices and instruct professionals in the handling of medical devices. It is suitable both for new entrants to the pro-fession and for updating and refreshing existing knowledge.
Referent
-
Jochen Harmuth
Senior QA and RA Manager
qtec services GmbH | Lübeck
Moderation
-
Leonie Schröder
Junior Consultant BVMed Academy
Bundesverband Medizintechnologie e.V. (BVMed) | Berlin
Programm
Detaillierte Veranstaltung
08:45 - Check-in/Registration
09:00 - Opening
Leonie Schröder
09:10 - Medical Devices Advisor | Part 1
Jochen Harmuth
- Welcome and introduction
- Legal Landscape
10:30 - coffee break
10:45 - Medical Devices Advisor | Part 2
Jochen Harmuth
- MDR in overview | Definitions, Labelling, Economic operators
- MPDG
12:30 - lunch break
13:30 - Medical Devices Advisor | Part 3
Jochen Harmuth
- PMS and Vigilance
- MPBetreibV and MPAMIV
- Summary and questions
15:00 - End of seminar
Teilnahmebedingungen
Anmeldung
The BVMed Academy reserves the right to change lecturers and/or postpone or change the program. If an event has to be canceled for reasons for which the BVMed Academy is responsible, only participation fees already paid will be refunded. Further claims are excluded.
Fotoaufnahmen
Stornierung
Auf einen Blick
Preis
- 360,00 € (pro Person, zzgl. 19% Mehrwertsteuer)
428,40 € (pro Person, inkl. 19% Mehrwertsteuer)
BVMed members - 420,00 € (pro Person, zzgl. 19% Mehrwertsteuer)
499,80 € (pro Person, inkl. 19% Mehrwertsteuer)
Non-members
Frist
Melden Sie sich bis zum 11. September 2024 an.