Andrew Rutter PhD

Andrew was with Ortho for nine years, working with New Product Development Teams and also in the International RA Team. Andrew was instrumental in Ortho’s Unique Device Identification (UDI) program, leading a cross-functional effort to meet the US FDA’s timeline in 2014 for Class III devices.

Andrew has more than 18 years of experience in the IVD industry, having previously worked for Gen-Probe Inc. (now part of Hologic) where he held the position of Quality Assurance and Regulatory Affairs Manager, and also fulfilled the role of European Authorised Representative.

Andrew has worked closely with Med Tech Europe (MTE) for several years particularly with Unique Device Identification, serving as the Chairman of the UDI Group, and also as an MTE nominated representative to the European Commission’s Steering Group for the development of the Eudamed III database to support the implementation of the new IVD and Medical Device Regulation.

Prior to industry, Andrew spent 11 years in the School Of Biosciences at Cardiff University where he gained a BSc (Hons) and PhD in Biochemistry.