European Medical Device Regulation / key changes overview (NTZ) A
At
TBA
For more information: https://www.eventbrite.com/e/risk-adjustment-documentation-and-coding-boot-camp-blr-s-tickets-55183166336
DESCRIPTION
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European Medical Device Regulation / key changes overview
This two-day seminar will provide you insights that allow you to identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.
In every company the situation and compliance level are different. The needs of companies also differ. Still, in most cases, it is advisable to start with a GAP-assessment covering technical documentation and QMS. The results will lead to a master impact matrix, which in turn gives the input for a strategic plan which outlines the realization phase and defines the projects that need to start in the implementation phase.
This seminar will give you the knowledge to start this process.
Why you should attend:
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This two-day seminar will provide key guidance and interpretation of the changes to the regulation and will be of value to all those who are involved in placing a medical device on the market, and anyone who requires an essential overview of the new medical device regulation and its impact on the industry and working practices.
The seminar will also present an approach for SME enterprises to manage the challenge of getting into MDR-compliance with reasonable efforts.
Areas Covered in the Session:
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Scope of the MDR and a definition of a medical device
Classifying medical devices under the European MDR
Conformity assessment procedures and the role of Notified Bodies
Safety and performance requirements
Navigating standards under 2017/745/EU
Clinical evaluations and "new rules" on adequacy of clinical data
etc...
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/risk-adjustment-documentation-and-coding-boot-camp-blr-s-tickets-55183166336
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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