Post Market Surveillance - trends, challenges and opportunities
When the latest Medical Device Directive came into force in March 2010, the requirements for Post Market Surveillance (PMS) were emphasised. Post Market Surveillance compiles information from many other areas – visualised in the figure below – and also results in feedback to these areas thereby influencing the whole company and ultimately business results.
The seminar focuses on how this can be dealt with in practice. How to achieve compliace to regulations while also achieving maximum benefit of the work that has to be done anyway. PMS requires the compilation of large amounts of information – used correctly this can give valuable data for new product development, improvement of existing products, for clinical trial work and so on.
The Danish Medicines Agency will cover the roles and responsibilities for this organisation covering PMS. Head of Department Ellen Jespersen will highlight which new initiatives that are expected during the coming revision of regulations and legislation.
Søren Sørensen, Lead Auditor Medical Devices from ConCare (representing DGM, the Danish Notified Body) will explain the role and responsibilities of the Notified Body. He will give examples of how PMS is documented when doing company inspections. Finally, Søren will elaborate on the adequacy of the Quality Management System (QMS) and how companies can fulfil documentation requirements for PMS within the scope of QMS.
Industry representative, Philippe Auclair, Chairman of the EUCOMED PMS Task Force will give an insight to the challenges of this industry when facing diverging demands from Competent Authorities. In addition, Philippe will give his view and perspective on the future of PMS in the light of the coming revision of the medical devices legislation.
Who should attend?
This seminar is of interest for (but not limited to) those responsible for post market surveillance and vigilance, quality- and regulatory affairs, risk management, clinical trial and sales and marketing
You can read more about the seminar here:
Programme - Seminar Post Market Surveillance