| Description: |
This course will help you to understand what ISO 13485 (medical devices - quality management systems - requirements for regulatory purposes) means for your organization. The course consists of both a practical and theoretical part. |
| Objective: |
At the end of the course you will know the basics of ISO 13485. You will have the required basic knowlegde to implement an quality management system in your organization.
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Who should attend:
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The course is intended for employees which are responsible for implementing an ISO 13485 quality management system. |
| Subjects: |
Subjects that are discussed during the course, are.:
- What are the standards requirements? (basic knowledge of ISO9001 is required)
- Which regulatory requirements apply?
- What is the relation with the medical device directive (MDD93/42/EC)?
- Practical case studies
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Duration:
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1 day
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Location:
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Apeldoorn area, The Netherlands
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| Number of attendees: |
minimum 6 and maximum 12 |
