Post Market Surveillance and Vigilance
Post-market surveillance including clinical follow-up, complaint and vigilance handling, impacts on all aspects of your organization's 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 your organization's continued compliance with the directives and identify consumer needs enabling continued product development.
Our “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.
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.
Who should attend?
- Regulatory professionals
- Quality managers
- Clinical affairs specialists
- Complaint handling specialists
- Design and development professionals
- Medical device sales and marketing