Module 16 2024

24/10/2024

The role and responsibilities of Approved Bodies and Notified Bodies in vigilance and Post Market Surveillance

Dr Monisha Phillips

London, 2024-10-24

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Monisha Phillips Head of Approved Body, TÜV SÜD

Monisha joined TÜV SÜD in 2021 as Head of MHS Certification Body (UK) where she is Head of Approved Body for medical devices. She led TÜV SÜD through the initial designation process as a UK Approved Body to our designation as an Approved Body for general medical devices and active implantable medical devices under the UK Medical Devices Regulations 2002 (as amended). She continues to lead the designation application to achieve designation as an Approved Body for IVDs. Monisha has over 20 years’ experience in the medical devices field with over 15 years working in EU Notified Body and UK Approved Body roles supporting delivery of conformity assessments under UK MDR, EU MDR and EU Directives. She is currently Co-President of Team-AB, a group which was formed in late 2023 and brings together Approved Bodies to share experience, coordinate practices and communicate with MHRA.

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

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