I joined Advena in 2016 and have progressed from consultant, senior consultant to my current position as Technical Director. I have over 12 years’ experience in medical devices within both industry and consultancy roles, I hold a degree in Chemistry and spent over 10 years in the pharmaceutical industry. My responsibilities include heading up the Regulatory Team and providing regulatory and quality consultancy to clients seeking to obtain or maintain CE marking to EU Medical Device Regulation (and legacy Directives) or UKCA marking according to UK Medical Device Regulation (MDR2002) for a broad range of medical devices. I undertake reviews and collation of Technical Files / Documentation to meet UK and EU regulatory requirements including, Clinical Evaluation Report to MDR Annex XIV and MEDDEV 2.7.1 rev 4, Risk Management to ISO14971:2019, Biocompatibility Plan and Reports to ISO10993-1:2018, Post market surveillance plans and Post market clinical follow-up plans. Additionally, I assist clients with ISO13485 related activities and I am a lead contributor in Notified Body client surveillance and re-certification audits.