网络研讨会：合规负责人(PRRC)

研讨会概览

根据欧盟MDR(EU 2017/745)与IVDR(EU 2017/746)法规第15条，制造商需和欧盟代表都需要任命一名医疗器械法规专业人员，作为合规负责人（PRRC），履行欧盟MDR和IVDR法规所规定的要求和职责。关于此条款，欧盟医疗器械协调工作组（MDCG）也发布了相应的指南文件MDCG 2019-07。

谁应该参与?

无论您是MDR和IVDR申请的新手，还是有和公告机构合作的经验，参加本次研讨会，都会帮助您了解公告机构对法规的解读。

• 医疗器械制造商
• 授权代表
• 管理者
• QA/RA
• MDR/IVDR负责人

您将收获

BSI全球法规负责人Maddalena Pinsi将为帮助企业理解MDR和IVDR的法规要求，任命合适的合规负责人（PRRC），并帮助合规负责人（PRRC）履行应承担的责任和义务。

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.