Learning Marketplace

ISO 14971: 2012 Risk Management and MDD Requirements

This webinar will focus on what medical device manufacturers need to know about European expectations regarding Risk Management and ISO 14971:2012. In most cases, the MDD 93/42/EEC, AIMDD 90/385/EEC, and IVDD 98/79/EC require more than compliance to ISO14971:2012. Join us to learn more about expectations from Europe and Notified Bodies.

Learning Objectives

Understand the content deviations in Annex ZA, ZB and ZC in ISO 14971:2012, and be able to conduct a gap analysis to meet the requirements of the standard.

Who Should Attend:

  • Medical device manufacturers who place medical devices, active implantable devices or in vitro diagnostic medical devices on the market in the EU.
  • Regulatory Professionals
  • Quality Professionals
  • Design Professionals
  • Clinical Professionals

Presenter

Dr. Suzanne Halliday leads training within BSI Healthcare. She has ten years of hands-on experience covering Design Dossier reviews, Technical Documentation audits and Quality Management System audits to ISO 13485 and European Directives. She has also conducted post-market clinical investigations on orthopeadic implants, and is also able to audit under numerous Mutual Recognition Agreements for compliance in Canada, the U.S., Japan, Taiwan and Australia.