Post-market surveillance including clinical follow-up, complaint and vigilance handling, impacts on all aspects of the quality management system. Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures applicable to all products.
By developing a post-market surveillance plan you can target sources of information enabling a cost effective product launch. Obtaining the right post-market information will ensure continued compliance with the directives and identify consumer needs enabling continued product development.
How will I benefit?
By developing a post-market surveillance plan you can target sources of information enabling a cost effective product launch. Obtaining the right post-market information will ensure continued compliance with the directives and identify consumer needs enabling continued product development.
How will I benefit?
This 1 day course is designed to help you identify the requirements of the European medical device directives (90/385/EEC, 93/42/EEC, 98/79/EC), standards and guidance documents to enable effective implementation of a post market surveillance system.
What will I learn?
On completion of this training, participants will be able to:
- Confirm the PMS regulatory requirements of the directives required for the particular class of product
- Create a procedure that includes both proactive and reactive sources of information
- Implement cost effective and targeted post-market clinical follow-up using various tools and techniques
- Recognise when a complaint needs to be reported as an incident
Who should attend?
- Regulatory professionals
- Quality managers
- Clinical affairs
- Complaint handling specialists
- Design and development professionals
- Medical Device Sales and marketing specialists
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