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Technical Documentation regarding MDR (Medical Device Regulation) - E-Learning

Know and understand the structure and requirements of technical documentation

Online Training70 minutesE-Learning
The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to provide a Technical Documentation for their devices. The Technical Documentation is a compilation of all relevant information on a product. It must be kept up to date throughout the entire defined product life cycle. The Technical Documentation forms the basis of the conformity assessment resulting in CE marking of a medical device. The main purpose of Technical Documentation is to prove that a medical device meets the General Safety and Performance Requirements (GSPR). New legal obligations include specified criteria set out in Annexes II & III for Technical Documentation on Post-Market Surveillance (PMS). There is also a strict requirement that the Technical Documentation shall be prepared in a clear, organized, unambiguous and readily searchable manner. Familiarize yourself with the basic requirements. This course does not require any special knowledge. The relevant basics are taught as part of the training. The learning module are equally suitable for beginners and refreshers.
  • Identify the requirements for Technical Documentation according to the MDR.
  • Summarize the requirements of the presentation of Technical Documentation according to the MDR.
  • Summarize the elements that Technical Documentation shall contain and identify any missing elements.
  • Find out who shall have Technical Documentation available and in what state/status
  • Product Verification and Validation
    • Specific requirements on Product Verification and Validation
    • Specific requirements on Pre-Clinical and Clinical Data
    • Specific requirements on Additional Information required in Specific Cases
  • Post-Market-Requirements
    • Requirements PMS (Post-Market-Surveillance) for the Technical Documentation - Annex III
    • Specific requirements on „The Post-Market Surveillance Plan”
    • Further requirements not included in Annex II and III
  • Technical Documentation Guidance for Manufacturers
  • Notified Body Involvement in Technical Documentation Assessment
Certificate of attendance TÜV SÜD Akademie
  • Every participant receives a personalised licence for using the contents of the e-learning course. This licence will be valid for 270 days.
  • The e-learning module is available in German and English.
  • Newcomers in the medical device industry
  • Expert and executive personnel seeking to update their knowledge
  • Personnel in charge of regulatory affairs
  • Personnel in quality management
  • Engineers in the medical device industry
  • Consultants in the medical device industry
Online
Geschäftskunden
Privatkunden
Nettopreis (zzgl. MwSt.)
100,00 €


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