Sandie Roth

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Sandie Roth joined QA Consulting in 2018. She advises on regulatory compliance, regulatory
submissions and quality assurance. 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.

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