EN ISO 13485:2016 Basic course – 2 dagar

En kurs som erbjuds av en av våra nätverkspartners, QAdvis.

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The course will go through all clauses and requirements and discuss interpretation and practical implications. It provides a basic understanding of the requirements and how to establish and maintain a well working quality management system.

Topic

  • 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
  • Practical exercises


Course material is in English. Verbal presentation and discussions in Swedish.

Date and location

21 – 22 May, 2019 in Malmö
Day 1: 09.30-16.30, registration and coffee from 09.00
Day 2: 09:00-16:00


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Besöksadress
Sveavägen 63, Stockholm

Postadress
Box 3601
103 59 Stockholm

Telefon 08-586 246 00 (vxl)

E-post info@swedishmedtech.se

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