Webinar “Fundamentals of conformity assessment for medical devices. Must-have for importer, Authorized Representative, and manufacturer”

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• 
  event_date November 7, 2023
• 
  event_time from 12:00 to 14:00 Kyiv time (GMT +2)
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  event_adress Online
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  event_language Ukrainian
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  event_speakers

  • Viktoriia Moroz, Key Account Manager
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  event_price

  • Free, subject to prior registration

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1. What is required to place medical devices on the market and put them into service;
2. How the class of the medical device impacts the certification procedure;
3. Procedure types: self-declaration, audit, CE recognition, batch certification;
4. Other "non-medical" technical regulations that may be applicable to medical devices;
5. Authorized representative of the manufacturer in Ukraine: role, duties, responsibilities;
6. What documents are required for conformity assessment;
7. National documents: labeling, instruction, check-list, declaration;
8. Registration of class I and IVD "other";
9. Audit and recognition of the CE certificate;
10. Market surveillance.

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