This one day introductory medical devices training course will give students a broad understanding of the ISO 13485 Quality Management Systems requirements, including the proposed revisions. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be introduced. This medical devices training course is highly interactive with lively debate and in-class discussion, real life examples, and exercises.
Who Should Attend
- Quality Managers
- RA Managers
- Auditors of Medical Device manufacturing firms (internal and external)
- Executives & Senior Management
- Cross functional team members of implementation project
Benefits to Your Business
Delegates are given an understanding of the relevance of various Medical Devices standards to industry in general, and to their own organization in particular.
Course Structure
- Understanding proper use of ISO 14969
- Understanding differences between ISO 13485:1996 and 2003 version
- Interpret all clauses of ISO 13485:2003
- Understand the essentials of ISO 14971 – The Medical Device Risk Management Standard
- Recognize the role of management in implementing and maintaining ISO 13485
Prerequisite
Knowledge of medical device manufacturing
Next steps
View our Medical Devices training course schedule.
For more information, please contact us or complete our enquiry form.
