Dates and Venues

Learn how to save time and audit costs by conducting a single audit of your medical device quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Through the Medical Device Single Audit Program (MDSAP), medical device manufacturers can perform just one audit of their quality management system to satisfy the standard and regulatory requirements of Australia, Brazil, Canada, Japan and United States.

This 2-day interactive course provides step-by-step guidance to the MDSAP audit approach, noting the specific requirements of participating countries at each stage. It includes a comprehensive and detailed look at tasks throughout the process, and offers delegates an opportunity to test their learning with group exercises. The course is led by a tutor who is both an industry expert and a practised teacher.

Those who would benefit from attending an MDSAP training course include:

  • quality managers
  • quality engineers
  • regulatory affairs professionals
  • auditors
  • anyone responsible for ensuring compliance with medical device regulations and standards, such as: FDA QSR, ISO 13485, and ISO 9001.

Additionally, those who work in quality control, production, design and development, and sterilisation may also benefit from this training.

We recommend that those wishing to attend have some basic knowledge of quality systems and auditing principles, such as ISO 9001 or FDA regulations. However, participants without prior experience can also benefit from the training, as the course will cover the basics of auditing quality management systems for medical devices.

Topics discussed on this course include:

  • history and overview of MDSAP
  • audit model
  • audit concept
  • audit sequence
  • audit NC grading
  • the companion document
  • FDA website
  • management process
  • device marketing authorisation and facility registration process
  • measurement analysis and improvement process
  • design and development process
  • production and service control
  • purchasing
  • technical documentation
  • audit times considerations
  • audit reports, review and assessment

The course agenda may vary depending on choice of delivery but will generally follow the structure below:

  • Day 1
    • Registration and Introductions
    • Session 1 Overview
    • Session 2 Audit Model
    • Group Exercises
    • Session 3 Management
    • Group Exercise
    • LUNCH
    • Session 4 Device Marketing Authorisation and Facility Registration Process
    • Session 5 Measurement, Analysis and Improvement
    • Group Exercise
    • Session 6 Medical Device Adverse Events and Advisory Notices Reporting
    • Group Exercise
    • Day 1 Review
  • Day 2
    • Day 1 Summary
    • Session 7 Design and Development
    • Group Exercise
    • Session 8 Production and Service Control
    • Group Exercises
    • Session 9 Purchasing
    • Group Exercise
    • LUNCH
    • Session 10 Technical Documentation
    • Session 11 Audit Time Considerations
    • Session 12 Audit Reports
    • Review and Assessment
    • CLOSE

MDSAP training enables attendees to develop essential skills to navigate the complex regulatory requirements of medical device manufacturing.

Skills gained can include:

  • regulatory and compliance knowledge
  • understanding of MDSAP requirements
  • identifying, managing and mitigating risks
  • audit preparation and management
  • continuous process improvement
  • audit data analysis to improve the QMS
  • communication and collaboration with stakeholders and across functions
  • problem-solving and decision-making

By completing this MDSAP training course, attendees will be well-prepared to support their organisation in achieving and maintaining MDSAP certification, ensuring compliance with international regulatory standards, and driving continuous improvement initiatives.