This course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

It provides hands on training to ensure that auditor thoroughly understands the role of an auditor and acquires the expertise needed or required to perform the ISO 13485 qms audits effectively. It is structured to provide in-depth understanding of ISO 13485 medical device quality management system requirements for regulatory purposes. With this medical device ISO 13485 training, participants will gain knowledge and skills required to assess the OH&S management system of an organisation. This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. It is a participative ISO 13485 training, which uses case studies, role plays, exercises, workshops and group discussions for improving the overall understanding of the participants.

Course Objective :

  • To enable delegates understand Key concepts in Medical Devices- Quality Management Systems- Requirements for regulatory purposes auditing
  • To impart/enhance practical auditing skills to become certified Internal Auditor
  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011

Who is it for?

Generally anyone involved in Medical Devices Industry but specifically,

  • Quality executives/managers,
  • Medical Device Importers / Software developers/validators.
  • R& D Personnel.
  • Regulatory Affairs personnel
  • Management representatives & QMS Consultants.
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Training Details

  • Register
  • IRCA Certified

    IRCA Certified ISO 13485:2016 LEAD AUDITOR COURSE
  • NOV 19th-23rd(5 days Straight Batch)

    DEC 19th-23rd(5 days Straight Batch)

  • Mode:

    Virtual Class Room

  • Duration:

    Varies based on the bacth selected

  • Fee:

    45000 INR + 18% GST

    [For Participants Within India]

    Contact Us For International Participant Pricing

  • For more details or any course registration please contact:

    Geetha Priya N

    Mob: 9150576959

    Tel: 044-49591335

    Mail: [email protected]

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