About Us

Peter Rose

BSc(Hons), CBiol, MSB, PCQI, MTOPRA

Principal Consultant, PRQR

Peter Rose is the founder and principal consultant of PRQR Ltd. With over 27 years of experience working in the field of Medical Devices and In Vitro Diagnostics, Peter has expertise covering Quality Assurance, Regulatory Affairs, Sterilisation and Cleanrooms.

Peter is a qualified Microbiologist, a Chartered biologist, Member of the Royal Society of Biology, Practitioner Member of the Chartered Quality Institute and a Member of TOPRA. Peter has an abundance of experience and expertise in Quality, Regulatory and microbiological matters for Medical Devices and IVDs across the UK and Europe.

Peter possesses a range of technical and business skills that enable him to provide unique insight to new and emerging businesses. He takes a hands-on approach to challenges and is adept at creative problem-solving. As a highly driven and entrepreneurial business leader, Peter has extensive senior leadership and board-level experience. As a well-regarded voice within the industry, Peters holds the position of Director within Medilink East Midlands, sits on a variety of industry committees and working groups and has been invited to address the European Parliament and Government ministers (see below for further details).

Peter's extensive experience includes the new Medical Device Regulation, the new IVD Regulation the three established Medical Device Directives, and International regulatory requirements including the US, Canada, and Australia. He also has expertise in quality management systems covering ISO 9001, ISO 13485 and 21 CFR 820 (QSR).

 

Key Experience

  • Medical Device & IVD Regulatory

  • Quality Systems

    • EN ISO 13485​

    • 21 CFR 820 (QSR)

  • Qualified Microbiologist & Sterilisation specialist

  • Chartered Biologist

  • Member of the Royal Society of Biology,

  • Practitioner Member of the Chartered Quality Institute

  • Member of TOPRA

  • Sits on: 

    • Medilink East Midlands Board

    • MHRA Medical Device Industry Liaison Group

    • ABHI Technical Policy Committee

    • ABHI MDR Implementation Working Group

    • ABHI Brexit Working Group 

  • Former Guest lecturer at 3 universities

    • The University of Nottingham

    • Nottingham Trent University

    • The University of Sheffield