EN ISO 13485:2016, 2-day course

EN ISO 13485:2016, 2-day course

This course explains the requirements of the standard and describe its interpretation and application. The course provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system. Having a quality management system according to ISO 13485:2016 is, in many cases, a prerequisite to getting a CE-mark.

Topics

  • ISO 13485 – History, purpose, scope and future
  • Quality management system – The big picture, CE-marking
  • Relation with ISO 9001 / LVFS / MDD / MDR
  • Requirements and interpretation of EN ISO 13485:2016
  • Quality management systems
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

Dela

Information

När: tis, 03 maj 2022 11:00 till ons, 04 maj 2022 18:00
Var: Lund, Medicon Village
Arrangör: QAdvis AB
Språk: Svenska
Pris: 11900 SEK
exkl. moms

Anmälan

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Kategori

Seminarium/utbildning

Kontaktinformation

QAdvis
08-621 01 05
academy@qadvis.com
https://www.qadvis.com/courses-and-seminars-2/