What
  • Company
  • doctor
  • health
  • hospital
  • Individuals / Other
  • Service/Vendor Providers
Where

Hey,

I’m  Sandie Roth. 

Clinical and Regulatory Consultant

01

about

Over the course of the last 15 years Sandie has managed many stages of the product life cycle including R&D, product development, device testing, quality, clinical, regulatory, marketing, and commercialization of orthopaedic devices predominantly in the areas of spine and upper extremity.  Her regulatory experience includes submissions through the US FDA 510(k) program, Technical Files and Clinical Evaluation Reports for the EU, and the Health Canada Special Access Program.  Additionally, Sandie has managed OUS pre-market clinical studies that were designed to provide clinical evidence for US and EU approval.  She has worked for large orthopaedic companies including Biomet and small start-up companies including Nexgen Spine and Wenzel Spine. Sandie holds an MSc in Medical Biophysics from Western University and a BASc in Mechanical Engineering from the University of British Columbia.

02

Contact

Let's connect...