Free seminar – Medical device standards and EU harmonization progress

QAdvis is a team of expert advisors in compliance,quality and productivity for the MedTech industry

QAdvis

Get an update on the big picture. What is actually going on in Brussels

Medicon Village, Byggnad Inspira Ground Floor. LOKAL: Sune

About this eventStandards are voluntary (well, almost all) but are still very important elements in demonstrating compliance with the regulatory requirements in EU MDR 2017/745 and IVDR 2017/746. This breakfast seminar provides a background to the purpose and benefit of European harmonized standards, the current status and the ongoing work driven by the EU Commission. The seminar in a follow-up of a previous webinar a year ago and will give an insight and update on the big picture.TopicsWhat is going on in MDCG Standards?Why is everything taking so long time?What can be done by the manufacturer in the absence of harmonized standards?What does “state-of-the-art” mean? Speaker: Nils-Åke Lindberg, Founder of QAdvis and Sr Principal ConsultantHe has more than 35 years of experience in the medical device industry. He is an active member of standard committee SIS/TK355, ISO/TC210 for quality management system aspects, e.g., ISO 13485. A stakeholder member of EU Commission MDCG working group for Standards since start representing the European Association of Authorized Representatives.Seminar language: Swedish, with English slide support. Any questions in Swedish/English.Seminar date: February 16, 20239:00 AM – 10:00 AM CET, including 15 min Q&A.Welcome to get some breakfast from 08.30, meet our speaker and mingle with other industry colleagues.Note: The event is free but space is limited. If you are not able to participate, we urge you to make a cancelation as soon as possible or assign your place to a colleague. If you register but don’t attend, you will be charged 300 SEK.

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Free seminar – Medical device standards and EU harmonization progress

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Free seminar – Medical device standards and EU harmonization progress

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