🇨🇿 QMS according to MDR / IVDR and what is missing in EN ISO 13485

The event is held in Czech language only!

The online seminar prepares you to handle the MDR and IVDR requirements related to the quality management system. The webinar will focus on the requirements that the regulations place on medical device manufacturers. It will also provide useful insight into the manufacturer's obligations for their critical supplier, to whom the quality management system requirements are directly transferred. These include, for example, suppliers outsourcing manufacturing. For distributors and importers, it will provide a link between their quality management system and the specifics of the MDR and IVDR. The course will explain the comprehensive requirements of the Regulation for a quality management system, as the original text of Article 10(9) of the MDR and Article 10(8) of the IVDR are somewhat abstract. The intersection between the requirements of the Regulation and the harmonised standard EN ISO 13485 will be discussed in detail. The main benefits and shortcomings of using EN ISO 13485 will be explained. The requirements of the regulation beyond the standard will be illustrated with examples of possible solutions.

Who the webinar is for:

• the quality staff of the medical device manufacturer

• regulatory specialists and PRRC of the manufacturer

• medical device contract manufacturing quality personnel (outsourced manufacturing) and other medical device manufacturer suppliers

• internal auditors

• regulatory specialists of distributors and importers

• personnel responsible for in-house manufacturing of medical devices at healthcare providers (Article 5(5) IVDR/MDR)

• anyone working in the healthcare sector who wishes to broaden their knowledge of the subject

Lecturers:

• Aleš Martinovský

• Barbora Charvátová

Content:

• analysis of specific MDR/IVDR requirements for QMS and how to meet them

• the role of EN ISO 13485:2016 in meeting the MDR/IVDR requirements for QMS

• gap analysis to EN ISO 13485:2016

• QMS and requirements for suppliers (medical device manufacturers)

• how to prepare for an MDR/IVDR certification audit

• the most common findings in MDR/IVDR audits

Additional information:

• during the webinar, participants will have the opportunity to ask questions

• each participant will receive a certificate of participation

• a PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

  ID: 03301931, VAT: CZ03301931

  registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město