C.V.

Joe Hagan-Brown

Joe is a QARA Consultant and the Director of MedRAS – a medical device consultancy firm, which he established in 2022. He has worked within the medical devices industry for over 10 years, in various roles and has a Batchelor of Science degree in Dental technology from the Manchester Metropolitan University. After working in Dental technology post-graduation, Joe worked for the UK competent authority – MHRA  between 2012-2019 as a Regulatory Affairs Manager; during which time, amongst other areas, he was responsible for leading the Joint Action on Market surveillance. He qualified as an ISO 13485:2016 lead auditor in 2013, and then went onto gain approval as an MHRA regulatory auditor. Joe conducted MHRA audits of Notified Bodies and manufacturers, and was a member of the European Commission’s Joint assessment team– conducting MDR designation audits of EU notified Bodies during the early stages of the MDR implementation project. In 2019, Joe left his role at the MHRA to take on a Notified Body auditor/ technical file reviewer role at Notified Body SGS (NB1639); gaining approval to audit under various regulatory / quality schemes including ISO 13485:2016, MDD, MDR, MDSAP and well as UKCA legal frameworks. Joe also managed a team of Notified body auditors during his time at SGS. In September 2022 Joe left SGS to establish MedRAS Consultants Limited – established an independent limited company, providing consultancy, project management, training and certification to people and organizations in the medical devices industry. Joe currently directs operations and delivers services to valued clients across the spectrum of the medical device industry in this role.