Regulatorik Quality Management according to EN ISO 13485 How to successfully set up and maintain a process-oriented quality management system
The seminar will be held in English
03.09.2024 09:30 Uhr - 04.09.2024 16:00 Uhr
organizer: BVMed-Akademie
Schwerpunkt: Regulatorisches
Zum Thema
EN ISO 13485 is based on the principles of ISO 9001 and the PDCA (Plan-Do-Check-Act) cycle. Nevertheless, EN ISO 13485 places far more requirements on a complete quality management system, which also increases the amount of documentation required. Learn about the structure and contents of EN ISO 13485 and find out how to set up, maintain and optimise your quality management system with the help of many practical examples.
The seminar will be held in English.
Zielgruppe
The seminar is aimed at Manufacturers of medical devices, Suppliers, subcontractors and sub-suppliers, Employees from quality assurance / quality management, Management, Process owners, auditors and Employees of authorities.
Referent
-
Timo Bohnhoff
Senior QA and RA Manager
qtec services GmbH | Lübeck
Moderation
-
Christopher Kipp
Regulatory Affairs Manager
Bundesverband Medizintechnologie e.V. (BVMed) | Berlin
Programm
Day 1 | 03. September 2024
09:15 a.m. - Participant Registration
09:30 a.m. - Welcome and Opening
Christopher Kipp
09:35 a.m. - Start of seminar
Timo Bohnhoff
- Introduction to quality management
- Regulatory requirements for medical devices
- Areas of application
- Documentation requirements
- Management responsibility and commitment
- Internal communication
- Quality policy
- Quality objectives
Break times
11:30 - 11:45 a.m. | coffee break
01:00 - 02:00 p.m. | lunch break
04.00 p.m. - End of seminar day 1
Day 2 | 04. September 2024
09:15 a.m. - Participant registration
09:30 a.m. - Reflection on seminar day 1
Christopher Kipp
09:35 a.m. - Start of seminar day 2
Timo Bohnhoff
- Management assessment, human resources, infrastructure
- Product realization
- Development requirements
- Procurement
- Measurement, analysis and improvement
- Practical examples/workshops: Implementing EN ISO 13485 in your own company
Break times
11:30 - 11:45 a.m. | coffee break
01:00 - 02:00 p.m. | lunch break
04.00 p.m. - End of seminar day 2
Teilnahmebedingungen
Anmeldung
Fotoaufnahmen
Stornierung
Cancellation free of charge is possible up to 5 working days before the start of the seminar. Thereafter, the full participation fee is due even in the event of non-participation.
Changes/Adjustments
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 re-sponsible, only participation fees already paid will be refunded. Further claims are excluded.
Auf einen Blick
Datum
Dienstag, 03.09.2024 09:30 -
Mittwoch, 04.09.2024 16:00
Programmflyer
Preis
- 895,00 € (pro Person, zzgl. 19% Mehrwertsteuer)
1.065,05 € (pro Person, inkl. 19% Mehrwertsteuer)
BVMed-Member| Seminardocuments are included. - 995,00 € (pro Person, zzgl. 19% Mehrwertsteuer)
1.184,05 € (pro Person, inkl. 19% Mehrwertsteuer)
Non-Member | Seminardocuments are included.
Frist
Melden Sie sich bis zum 2. September 2024 an.
