Course Description
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.
BSI’s “Post-market Surveillance and Vigilance” 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.
Who should attend?
- Regulatory professionals
- Quality managers
- Clinical affairs specialists
- Complaint handling specialists
- Design and development professionals
- Medical Device Sales & marketing
This course will enable you 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
Course Prerequisite
Participants should have experience with or basic knowledge of quality management systems for the medical device industry or experience of the manufacture, design, marketing or use of medical devices.
Further information
Fee: 1-day post-market surveillance and vigilance training course including refreshments, lunch and course notes - £695 + VAT.
Attendance on this course will provide delegates with 8 CPD points.
This course can be delivered as in-company training, customized for specific organizations and their circumstances.
