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.
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
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.