Petra Kaars-Wiele

Abbott, Germany

Petra graduated from the University of Goettingen/ Germany with Diploma in 1980 and with Ph.D. in 1983. She joined Abbott Laboratories in the same year.

Petra has more than 35 years of experience in Regulatory Affairs and Quality Systems for Medical Devices, currently responsible for all international regulatory matters, medical event reporting, risk management, managing translation for 29 languages and labeling activities at Abbott Diagnostics Division. She has experience in building Quality Management System according 9001 and 13485 and has passed a lead auditor training in 1997. Since then she has used that knowledge in training, setting up a QMS or consulting in that field internally and externally.

Petra is retired from Abbott since April 2019 and is working as an independent Consultant.

Other Activities include:

  • Advisor to AHWP Technical Committee
  • Chairwoman of the EDMA Globalization Working Party dealing with new and revised worldwide regulations
  • Member of the EDMA Regulatory Committee and Technical Forum
  • Past Member of the GHTF SG1, IVD Subgroup representing EDMA, from 2003 until 2012
  • Trainer activities for EU Commission, AHWP, ASEAN, APEC and USAID and WHO
Broadcast Timezone CET

The conference will be broadcast at Central European Time (CET).  Please refer to the program on the virtual conference platform for the final timings of each presentation and the LIVE Q&A’s.