Course code
PT221
Duration
Minimum of 16 hours

This course aims to provide learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP AU P0002.005) for medical device quality management.

This is based on ISO 13485:2016 and international regulatory bodies medical device regulations. Audit principles in accordance with ISO 17021.

Reference to existing CQI units/courses:

  • MD-QMS ISO 13485:2016 Foundation (FD132)
  •  MD-QMS ISO 13485:2016 Lead Auditor (PR369)

Who is it for?

This course is for those involved in ensuring compliance with and needs an in-depth understanding of IMDRF Medical Device Single Audit Program (MDSAP AU P0002.005) for medical device quality management based on ISO 13485:2016.

Learning outcomes

Knowledge

1. Explain the purpose of a medical device single audit program (MDSAP) medical device quality management system audit process in the context of ISO 13485 and regulatory compliance.

2. Explain the role and responsibilities of an auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 17021, regulatory body requirements and the MDSAP audit criteria.

Skills

3. Plan for and conduct an audit of a medical device quality management system, report, and grade non-conformities to establish compliance with ISO 13485 and regulatory requirements using MDSAP methodology.

Recommended prior knowledge

ISO 13485

  • Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Lead Auditor (PR369) training course or equivalent.

Medical device management systems

Knowledge of the following quality management principles and concepts:

  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
  • The process approach used in quality management.
  • Understand risk management principles related to the design of a medical device quality management systems (e.g. through ISO 14971).

Assessment 

Learners must demonstrate acceptable levels of performance in the three learning objectives to complete the course successfully. Learners will be assessed through a short, written quiz/quizzes or tests. As well as performance in a practical audit situations.