Course Description
This one-day introductory course will give students a broad understanding of the ISO 13485 Quality Management Systems requirements. 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
- Regulatory Affairs managers
- Auditors of Medical Device manufacturing firms (internal and external)
- Executives and senior management
- Cross-functional team members of implementation project
- Knowledge of medical device manufacturing is a prerequisite to attending this course.
Benefits to Your Business
Delegates are given an understanding of the relevance of ISO 13485 Quality Management System Standard in general enabling application to their own organization.
Course Structure
- Understanding the concept of ISO 13485:2003
- Identify the links with the eight management principles
- Understanding the application of ISO 13485:2003
- An introduction to ISO 14971 the Medical Device Risk Management Standard and its use with ISO 13485
- The role of management in implementing ISO 13485
Further Information
Fee: One-day course including refreshments, lunch and course notes £375 + VAT.
Attendance on this course will provide delegates with 8 CPD points.
