Manager regulatory Affairs
Within five days this seminar is providing special know-how for people responsible for regulatory affairs.
Abridgement from the seminar programm:
- ISO 13485 and MDD 93/42/EEC;
- Technical Documentation;
- Current Good Manufacturing Practices (cGMPs);
- Premarket Notificatons 510(k);
- Biocompatibility ISO 10993;
- Hygiene, Clean Room Environment;
- Marekting Approval Procedures of Canada, Japan, Australia.
The seminar is closed by an exam and participants with more than 70% correct answers have passed the test.
Interessted? Than register for more informations >> Seminars.