🇨🇿 Quality agreements: Practical tips for manufacturers, importers, and distributors of MDs and IVDs

The event is held in Czech language only!

Quality agreement (QA) is one of the most important pillars of the quality management system. It is a prerequisite for compliance with MDR / IVDR and a critical factor for obtaining EU certification, as notified bodies insist on the existence of precise QAs. However, drafting a QA that satisfies all parties, covers the minimum requirements, and is successfully concluded in the form of a signed QA is a major challenge.

This webinar is designed to cover a range of needs, from novice specialists who need to familiarize themselves with the basic parameters of quality agreements to experienced quality professionals who want to deepen their knowledge and optimize contractual relationships with business partners. The aim of the webinar is to provide participants with a comprehensive overview of the preparation and conclusion of QAs. The webinar reflects both the basic requirements of legal regulations and standards, as well as real-world experience. 

Who the webinar is for:

• Regulatory specialists of manufacturers, importers, and distributors of MDs and IVDs

• Quality management department employees

• Purchasing department employees

• Sales / marketing / customer relations department employees

• Legal department employees

• Quality management system auditors

• Persons in the role of PRRC

• Auditors from the ranks of notified bodies

• Anyone who works in the field of medical devices and wants to broaden their horizons on this issue

Lecturers:

• Mgr. Aneta Dostálová

• Ing. Petr Votava

Content:

• What is QA, its benefits for manufacturers, importers, and distributors

• QA from the perspective of legislation, standards, and recommended documents

• Content requirements for supplier QA

• Content requirements for distribution QA

• Practical tips for concluding QA

  
  

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