Webinar: Person Responsible for Regulatory Compliance (PRRC)

Datum: 28. Juli 2021

Zeit: 10:00 -11:00 CET und 17:00 - 18:00 CET

Sprache: Englisch

What’s this webinar about?

With the MDR and IVDR, European regulators need to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal. This will ensure that the company is meeting certain specific EU requirements. The Medical Device Coordination Group has endorsed and made available the MDCG 2019-07 guidance on this topic.

BSI Notified Body would like to provide an overview of the requirements and some practical considerations.

Who should attend the webinar?

This webinar will offer notified body insights for all people involved in working towards an IVDR and MDR application, whether you are a novice or have significant experience of working with a notified body.

• Medical device manufacturers
• Authorized Representatives
• Management
• QA/RA professionals who will be responsible for regulatory compliance
• Professionals preparing for the MDR/IVDR

What will participants gain?

Join this insightful webinar to hear from, Maddalena Pinsi, Regulatory Lead, BSI, as she explains how to gain a better understanding of the requirements as well as insights on some practical considerations to be considered when implementing them within your organization.

Maddalena holds a Master Degree in Medical Biotechnology and has over 12 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 in BSI, working along with the Head 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.