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With more than 500,000 different products, the global market for medical technology is very diverse and technologically demanding. At the same time, the industry is strictly regulated - due to normative and legal requirements, manufacturers have to carry out complex certification and approval procedures. It is therefore not easy for newcomers to find their way in the complex environment.
This is exactly where the seminar comes in: The participants receive a comprehensive overview of the obligations of the manufacturers of medical devices before they are placed on the market. The focus is on the European regulations. The importance and tasks of important authorities and the notified body are also discussed, as well as the different procedures for assessing the conformity of medical devices.
After completing the seminar, the participants will have the necessary basic knowledge to be able to exchange ideas with customers, suppliers and other partners from the industry on an equal footing.
topic overview
- Definition of medical devices
- Importance of the safety and performance of medical devices and their evaluation
- Purpose of medical devices and risk classes
- Basics of technical product documentation and product certification
- Post-market surveillance (vigilance procedure)
- Communication with the relevant authorities
target group
Newcomers to the medical technology industry, as well as employees from different areas such as QM, regulatory affairs, R&D, manufacturing, sales and other service areas.
previous knowledge
Not required (introductory seminar).
KONTAKT:
Online
