Medical device consultant as per Section 83 of the German Medical Device Law Implementation Act (MPDG)
Description:
In order to provide expert groups with specialist advice, or to teach them how to deal with medical devices correctly, in-depth knowledge and experience of the medical devices in question is required. This practice-oriented seminar explains the knowledge needed to perform the role of a medical device consultant as per Section 83 of the German Medical Device Law Implementation Act (MPDG), as well as the legal principles in medical device law.
Contact Person:
Goals
This seminar provides participants with the required knowledge of the legal principles behind medical devices in Europe and Germany. It offers an insight into the process of conformity assessment for medical devices and an overview of the requirements for the CE marking. In particular, this seminar deals with the legal responsibilities and tasks of medical device consultants in a practical manner.
Seminar content
- Legal principles: EU regulations, German law (MPDG)
- The basics regarding classification of medical devices, conformity assessment and CE marking
- Tasks and responsibilities of medical device consultants as per the MPDG and their interpretation
- Involving the role of a medical device consultant in post-market surveillance processes and vigilance
- Responsibilities in Germany: Vigilance authority, market surveillance by authorities
Target group / seminar duration and certificate
Medical device consultants as per Section 83 of the MPDG, employees of manufacturers and distributors (e.g. sales staff, field representatives, independent sales representatives, employees of healthcare suppliers, and staff in the fields of sales, field services, order processing, product management).
The content is presented over the course of a one-day seminar. Following the seminar, participants then take a test to check their knowledge. They receive a certificate of attendance and, on request, materials for participants in physical or digital form.
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