Objectives

• Understand the importance of Quality and why medical devices must be designed for safety.
• Understand why medical devices are important and why they must be designed in a way to be safe and work as intended.
• Understand that the QMS requirements for medical devices are specific (and different to those for pharmaceuticals).
• Understand there are different QMS requirements in US, Australia, Canada, UK and EU.
• Understand the PDCA cycle within an ISO 13485 QMS and be aware of the 5 key areas of ISO 13485:
  • General Requirements
  • Management Responsibility
  • Resource Management
  • Product Realisation
  • Measurement, Analysis and Improvement

Topics

1. Welcome
2. Introduction to Quality
3. Quality Management Systems
4. Quality Management Systems for Medical Devices
5. Wrap Up

Participants

This course is designed for the induction of personnel interested in or new to the medical device industry.

Assessment / Certificate

There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.

A digital credential (badge) will be issued from Credly on e-mail after the quiz assessment is passed.

Duration

The course is expected to take approximately 1 hour.

Your licence grants you access to the course for 30 days.

Refer to the Terms and Conditions.

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