Regulatorik Risk Management for Medical Devices EN ISO 14971 and Medical Device Regulation (MDR) Regulatory requirements for risk management
The seminar will be held in English
10.12.2024 09:30 Uhr - 12.12.2024 16:00 Uhr
organizer: BVMed-Akademie
Schwerpunkt: Regulatorisches
Zum Thema
In this interactive seminar, you will learn how to implement and document a professional risk management process according to ISO 14971, consider the influences on interfaces such as Technical Documentation including Clini-cal Evaluation and Usability for Use, and derive necessary measures for risk control. Many illustrative examples and concrete tips will help you to apply the requirements to your company and your products.
Notice
The seminar will be held in English.
Zielgruppe
This seminar is aimed at Manufacturers of medical devices, Risk managers and members of a risk management team, Regulatory affairs managers, Quality management officers and Auditors.
Referentin
-
Dr. Claudia Rampp
Senior RA and QM Manager
qtec services GmbH | Lübeck
Moderation
-
Christopher Kipp
Regulatory Affairs Manager
Bundesverband Medizintechnologie e.V. (BVMed) | Berlin
Programm
Day 1 | 10. Dezember 2024
09:15 a.m. - Participant Registration
09:30 a.m. - Welcome and Opening
Christopher Kipp
09:35 a.m. - Start of seminar
Dr. Claudia Rampp
- Introduction into Risk Management
- Risk Management according to ISO 14971:2019
- Risk Management Process – Part 1
- Risk Management planning
- Risk analysis – Hazard identification
- Risk management tools
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 | 12. Dezember 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
Dr. Claudia Rampp
- Risk Management Process – Part 2
- Risk analysis – Risk assessment
- Risk evaluation – Acceptance criteria
- Risk control – Manage the risk
- Risk management review
- Risk Management Documentation, Data flow, Interfaces
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, 10.12.2024 09:30 -
Donnerstag, 12.12.2024 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 9. Dezember 2024 an.
