egulatory, Quality and Information Security expert in the field of medical devices.
Experience with implementing:
- Quality Management systems per ISO 13485
- Information Security Management systems Per ISO 27001
- Regulatory Affairs per MDR, Health Canada, FDA, and acting as PRRC
- Privacy Regulations per GDPR (2016/679), and acting as DPO
Additional knowledge and understanding of the current field of standards around software medical devices, and those enabled by AI (i.e. deep-learning technology).
