MDR - The New European Medical Device Regulation (English)
WHEN
From: 05. Mar 2020
To: 05. Mar 2020
WHERE
Helsinki, Finland
LANGUAGE
The training will be conducted in English
COST
629€ (+VAT24%)
Register
Contact us to enquire about this session
SGS Academy will organize a seminar
MDR: The New European Medical Device Regulation
The European Union Medical Device Regulation (MDR) 2017/745, which replaces the existing Medical Device Directive (93/42/EEC), applies to all EU countries and all medical device manufacturers, importers, and distributors. Join the seminar to discover how the new MDR impacts your business and its requirements.
Time and place:
5th March 2020, 9 am – 4 pm in Helsinki (Registration and breakfast starting 8.40 am)
SGS Fimko Ltd., Takomotie 8, 00380 Helsinki
Participants:
Seminar is aimed at people who are responsible for: design and development regulatory requirements placing devices on the market import, distribution, or sales
Objective and content of the seminar:
The objective of the seminar is to give a comprehensive insight of the new MDR.
- Overview of the new MDR
- roles of different economic operators throughout the device life cycle
- essential requirements
- content of device technical file
- pathway and stepping stones into medical device market
- risk management throughout the device life cycle
- What changes do the new MDR requirements introduce compared to current legislation
- changes in device classification
- stricter rules for class III device approval
- New requirements, e.g.
- UDI – Unique Device Identification, unique device identifier for better traceability
- requirements for quality management system
- person responsible for regulatory compliance
- prohibition of misleading information of the device
- responsibilities of importers and distributors
- medical device nomenclature
Participants may send questions in advance by Feb 27th 2020 to Anne Paakkunainen. The questions will be addressed during the course by the seminar experts.
Seminar experts:
The seminar is held by SGS Fimko Medical Device experts Seppo Vahasalo (Notified Body Manager), Jani Högman (Lead Auditor) and Mari Levula (Lead Auditor).
Price:
A one-day-course costs 629 € per delegate. If there are other participants from the same company, price is 529 € per next delegates when charged in a same invoice. Students -50%, Healthtech Finland membership -50 € discount from the basic price (please add info in the “Additional information” text field).
Price includes course material, breakfast, lunch and afternoon snack. This training will be pre-invoiced and the payment is required before the training. VAT 24 % will be added.
Registration:
Please register 19.2.2020 at latest. Registrations through the registration link at the top of the page.
General terms and conditions:
This training will be conducted in English. SGS Fimko Ltd. can change the lecturer and the venue. In case a delegate cancels the training later than two weeks before the agreed training date, 50% of the training fee will be charged. If delegate cancels the training later or does not cancel at all, the training fee will not be returned. The place can be transferred to another person if necessary. SGS Fimko Ltd. reserves the right to cancel the training two weeks prior if the number of delegates is too low. We will not reimburse the customer for any charges caused by such cancellation.
For more information, please contact:
Seppo Vahasalo, tel. (040) 560 9500
Anne Paakkunainen, tel. (09) 6963 428
You can also contact us via the link below: