SGS webinar on IVDR & MDR certification process
Are you supporting manufacturers in navigating the IVDR or MDR certification process? Join our complimentary online session designed specifically for consultancy companies working with IVD and medical device manufacturers in Sweden. This informative and practical session will provide an overview of the different stages of the certification process, as well as the working methods, expectations, and requirements of Notified Body SGS Fimko NB 0598, illustrated through practical examples and case-based discussions. Teams-webinar on Fri, 9.10.2026 at 9:00-10:30 (Swedish time)
Agenda
Topics:
- A brief introduction of SGS Fimko
- Overview of the IVDR and MDR certification process containing:
Application phase (Questionnaire, Sampling plan, Notified Body offer and quotation process)
Technical Documentation Assessment
Audit phase
- Certification timeline and key milestones
Speakers:
Petra Leppimäki (in Swedish), IVDR Expert, Lead Auditor, SGS
Ilkka Juuso (in English), MDR Expert, Lead Auditor, SGS
Mari Levula (in English), Head of Notified Body IVDR NB Manager, SGS
What You Will Learn
Following this session, you will have a better understanding of how a Notified Body operates, its expectations and requirements, and the documentation needed at each stage of the certification process.
The event also provides an opportunity to meet representatives of the Notified Body and discuss certification-related topics directly with SGS experts, who will be happy to answer your questions throughout the session.
Please register by Thu, 8.10.2026 at 9:00 (Swedish time)
We look forward to seeing you at our event.
https://www.sgs.com/en-se/webinars/2026/10/ivdr-and-mdr-certification-process
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