Training ISO 13485 basics
| 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.
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| Objective: |
At the end of the course, you will know the basics of ISO 13485. You will have the required basic knowledge to implement a quality management system in your organization.
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| Who should attend: |
The course is intended for employees who are responsible for implementing an ISO 13485 quality management system.
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| Subjects: |
Subjects that are discussed during the course are.:
- What are the requirements of the standard? (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: |
1 day
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| Location: |
in-company
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| Attendees: |
maximum 8
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