Nick has over 20 years experience in regulatory affairs for IVD’s first at the British Standards Institute and then at Lloyd’s Register Quality Assurance (LRQA) first as technical manager and then Head of IVD Notified Body managing the global service for CE certification of IVD medical devices. Prior to this he spent 13 years in the diagnostics industry working on a variety of infectious diseases and clinical chemistry assays in both production and research and development.
His current position is as the IVDR Certification Manager at DNV Product Assurance AS. He was also chairman of the Notified Body Recommendation Group responsible for producing guidance documents for approval by the NB-MED group and also was a member of the MHRA IVDR task force group during the drafting of the IVDR.
