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.
How will I benefit?
- Give your organization the competitive edge
- Allow your organization to evaluate the medical devices that you have available on the market, and track their performance
- Allow your organization to implement an effective post-market surveillance system
- Continually manage your medical devices risk according to global best-practice
- Boost employee, customer and stakeholder confidence
Who should attend?
- Regulatory professionals
- Quality managers
- Clinical affairs specialists
- Complaint handling specialists
- Design and development professionals
- Medical device sales and marketing
What will I learn?
- 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
- Recognize when a complaint needs to be reported as an incident
What is included?
- Detailed training course notes
- A loan copy of the standard, for use during the course
- Internationally recognized BSI Training Academy certificate
Prior knowledge and learning
You should have experience or basic knowledge of quality management systems for the medical device industry. We recommend you have a basic awareness of medical regulations, medical device development or quality assurance.
Future recommendations
- Lead Auditor: ISO 13485 - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
- Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
