Course Description
This one day introductory 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 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
Further Information
Fee: one-day non-residential course including refreshments, lunch and course notes
Please contact BSI Training on +91 (0)11 2692 9000.
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