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    Medical devices

    Quality management system according to EN ISO 13485:2016 – in practice

    The two-day course, in cooperation with Intertek Academy, provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system.

    The harmonized EN ISO 13485:2016 standard can be used to show compliance with the regulations and constitutional requirements needed for companies supplying medical devices and associated services in the EU/EEA. By implementing a quality management system according to this standard, you fulfill many applicable sections of both Medical Device Regulations (MDR 2017/745 and IVDR 2017/746).

    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 and MDR/IVDR
    • Requirements and interpretation of EN ISO 13485:2016
    • Quality management systems
    • Management responsibility
    • Resource management
    • Product realization
    • Measurement, analysis and improvement

    Target group

    This course is intended for personnel within QA, development, production and management, as well as for internal auditors, process owners, and regulatory staff at companies within the medical device supply chain. A basic knowledge of quality systems, such as ISO 9001, 13485, GMP, etc. is recommended.

    Objectives

    After the course, participants will have a basic understanding of the ISO standard and how to establish and maintain a quality management system based on it.

    Additional information

    The course costs 14 300 SEK (excluding local VAT). The course material is in English, and the course will be held in English.

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