Providing meticulous regulatory support to the medical device, in vitro diagnostic and pharmaceutical industries.
Expertise in:
- Regulatory strategy
- EU Medical Device Regulation and Invitro Diagnostic Device Regulation
- US FDA 510(k), PMA, IDE
- Global Registrations
- Oncology Companion Diagnostic Devices
- Drug Device Combination Products
- Orthopaedics
To discuss your requirements and availability, please contact Dr. Heather Johnson by email at