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Medical device single audit program (MDSAP)

This work item is now complete. This page has been retained for historical reference.

The Medical Device Single Audit Program (MDSAP) Work Group has completed its work and has moved to the implementation phase. For current information on implementation see MDSAP

The Working Group will develop a standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers' quality management systems. The document will be applicable to competent authority auditing groups/inspectorates, as well as third party organizations that conduct such audits. This is an initial critical step in establishing a single audit program. This action will complement the current ISO13485 revision process under which IMDRF seeks modifications to achieve a harmonized standard amongst its members.

There is a current consultation concerning the Medical device single audit program (MDSAP), which will close on the 14th of December 2012.

Working Group Chair: Kimberly Trautman, US FDA. contact Kimberly Trautman

Working Group Membership: Regulator membership

Australia

  • Keith M Smith
    Quality System Inspector
    Office of Manufacturing Quality
    Therapeutic Goods Administration

Brazil

  • Alba Maria Campos Pismel
    Medical Devices Inspection Coordinator
    Office of Medical Devices Inspection
    General Office of Inspection
    Brazilian Health Surveillance Agency, ANVISA
  • Patricia Serpa
    Health Surveillance and Regulation Specialist
    Office of Medical Devices Inspection
    General Office of Inspection
    Brazilian Health Surveillance Agency, ANVISA
  • Vivian Cardoso de Moraes
    Especialista em Regulação e Vigilância Sanitária
    Office of Medical Equipment
    General Office of Medical Devices
    Brazilian Health Surveillance Agency, ANVISA

Canada

  • Nancy Shadeed
    Therapeutic Products Directorate
    International Programs Division
    Health Canada

China

  • Zhu Ning
    The Department of Medical Device Supervision
    Chinese Food and Drug Administration
    CFDA
  • Wang Aijun
    The Center for Food and Drug Inspection
    Chinese Food and Drug Administration
    CFDA
  • Tian Shaolei
    The Center for Food and Drug Inspection
    Chinese Food and Drug Administration
    CFDA

Europe

  • Rob Higgins
    Regulatory Affairs Section Head
    Medicines and Healthcare products Regulatory Agency (MHRA)

Japan

  • Hideyuki Kondo
    Deputy Director
    Office of Medical Devices Evaluation
    Pharmaceutical and Food Safety Bureau
    Ministry of Health, Labour and Welfare
  • Kenichi Ishibashi
    Office of GMP/QMS Inspection
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Yoichi Onodera, D. Eng
    Deputy Review Director
    Office of Medical Devices III
    Pharmaceuticals and Medical Devices Agency (PMDA)

United States

  • Kimberly Trautman MSc (Chairman)
    Medical Device International Quality Systems Expert
    Associate Director, International Affairs
    Center for Devices and Radiological Health (CDRH
    US Food and Drug Administration
    Email: kimberly.trautman@fda.hhs.gov

IMDRF Official Observers and Affiliate Organization Representatives

  • Ali Al-Dalaan MBA.IT
    Chair AHWP WG3
    Vice Chair Technical Committee
    Asian Harmonization Working Party
  • Sabine Ohse
    Technical officer - Inspections
    Diagnostics and Laboratory Technology Team
    Essential Medicines and Health Products
    World Health Organization