Post-market surveillance including clinical follow-up, complaints, and vigilance handling, are vital in ensuring compliance with the EU medical device directives and are an essential component of a 13485 Quality Management System. Devices in pre-CE marking clinical investigations are subject to adverse event reporting that is comparable to post market vigilance reporting.

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.

Learning Objectives

On completion of training, delegates will be able to:

• Confirm the regulatory requirements for PMS for the particular class of product, and how these are interpreted in ISO 13485, ISO 14971 and various European & GHTF guidance documents.
• Create a Post-market Surveillance 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.
• Recognize when a complaint needs to be reported as an adverse event or incident for both pre and post CE marked devices.

Who Should Attend

• Regulatory professionals
• Quality managers
• Clinical affairs specialists
• Complaint handling specialists
• Design and development professionals
• EU authorized representatives

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.

This course can be delivered as in-company training, customized for specific organizations and their circumstances.