"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Medical Device equipment

Effective Management Controls
– for Medical Device Firms

Course description:

This course provides you with the knowledge and confidence to interpret the ISO 13485:2016 and US Food & Drug Administration’s Management Responsibility requirements in the Quality System Regulation for your company’s operations.

In one fast-paced day, you will learn the key requirements of executive leadership for establishing and monitoring the Quality Management System in a risk-based paradigm for medical device or combination product companies.

Course outline:

  • Management Responsibility, including Management Review and personnel
  • A subsystem model for evaluating Quality Management System effectiveness
  • Key quality indicators in the QMS
  • Corrective and Preventive Action from an executive perspective
  • Internal quality audit from an executive perspective
  • Using risk in the QMS infrastructure
  • Risk-based decisions – where they are appropriate
  • Examples of implementing a risk-based management model

Note: This course is presented electronically. Each attendee must bring their own laptop to the course venue, Adobe PDF Reader is essential to fully participate in the course.

Course objectives:

  • Review and discuss the Management Responsibility requirements.
  • Highlight key data in the Quality Management System that support Management Review and executive decision-making.
  • Discuss Corrective and Preventive Action and internal quality audit as key executive management support tools.
  • Discuss context of risk-based decision making and review opportunities to adopt a risk-based approach throughout the QMS.

Who should attend:

Intended for executive management of medical device or combination product companies, this fast-paced course is ideally suited to staff with responsibility for evaluating effectiveness of a Quality Management System. It is also intended for Management Representatives, and key staff responsible for Internal Audit.



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Course facts

Course no:
Medical Device industry

US and EU


Date, location and venue:

This course is only offered in-house.
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1 day

Price (excl. local VAT):
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