ISO 13485:2016 – Medical Device- Quality Management System

Course Description

ISO 13485:2016 is a quality system management standard. It’s similar to ISO 9001 but has a few more stipulations to help companies meet the more specialized demands that come with making medical components and healthcare related products.

Course Content

  • Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
  • Explain the role and responsibilities of an auditor to plan, conduct, report, and follow- up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021.
  • Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.

Target Audience

This course is specially designed for who is or Aspires to be:

  • A Third-Party Assessor or Lead Assessor of ISO 13485:2016
  • Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
  • Responsible for implementing internal audits and audit programs as per ISO 13485:2016
  • Responsible for implementing the ISO 13485 series of standards

Course Information

Mode: Virtual Class

Course Duration: 40 hrs [5 days]

Course Fee: S$1500

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