Comprendre les rapports périodiques de sécurité et comment soumettre votre PSUR à BSI (contenu en anglais)

What is the webinar about?

This webinar will provide manufacturers with an understanding of BSI expectation in relation to PSURs and provide an overview of the recent guidance related to PSURs (MDCG 2022-21). Manufacturers will also learn how and when to submit PSURs to BSI using the BSI Electronic Client Portal and also when they are required to update and provide SSCPs alongside the PSUR.

Who should attend?

All clients of BSI.

What will participants gain? 

• An understanding of BSI expectations in relation to PSUR.
• An overview of MDCG 2022-25.
• How to correctly submit PSURs to the notified body.
• When to submit SSCPs alongside PSURs.

Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electro physiology.

Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Maddalena holds a master’s degree in Medical Biotechnology and has over 14 years of experience gained both within industry and BSI.

During her industry career, she developed and executed regulatory strategies to secure regulatory approvals on a global scale, translating regulatory requirements into project/product requirements.

In her current role at BSI, working along with the Heads of the Notified Body and Head of the UK Approved Body, she develops processes and procedures to ensure compliance with the various legislative and designation requirements.