🇨🇿 Technical documentation as part of managed documentation: tips for management and structuring

The event is held in Czech language only!

Technical documentation (TD) represents a key pillar for demonstrating the conformity of medical devices, yet its correct understanding often poses a challenge. This webinar is designed to cover a range of needs, from novice specialists seeking a quick overview of the legislative framework to experienced regulatory experts who want to deepen their knowledge or optimize and streamline related processes for medical device manufacturers.

The aim of this webinar is to provide participants with a comprehensive overview of the creation, structuring, maintenance, and updating of TD in accordance with the MDR. The webinar reflects basic legislative requirements as well as real-life insights and interpretive practice of notified bodies.

Who the webinar is for:

• Regulatory specialists of medical device manufacturers

• Quality management department employees

• Quality management system auditors

• Documentation management specialists

• Persons in the role of PRRC

• Product evaluators and auditors from notified bodies

• Anyone who works in the medical device industry and wants to broaden their horizons on this issue

Lecturers:

• Ing. Petr Votava

• Ing. Aleš Martinovský

Content:

• Documentation management in general – EN ISO 13485 requirements

• Updating TD – proper implementation of updates, correct documentation practices, link to production (traceability), planned and "forced" updates

• What does it mean that TD must be presented in a clear, organised, readily searchable and unambiguous manner?

• Recommended TD structure for Class I medical devices

• Recommended TD structure for higher risk classes of medical devices for manufacturers whose NB does not have specific requirements for its management/submission

• How to deal with specific requirements for TD structure at some NBs

• Role and concept of the TEAM-NB association

  
  

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