Michaela Shaw, Director of Quality Assurance and Regulatory Assurance
Michaela brings over 15 years experience within the medical device industry where she worked with a variety of start-up companies, leading them through the FDA, Health Canada and EU regulatory approval process. Michaela’s experience includes many noteworthy product and device regulatory approvals in the area of medical imaging, cardiovascular and respiratory therapy, medical device software and point-of-care diagnostic devices.
Michaela has provided quality and regulatory assistance to a variety of companies within the IVD, Medical Device, consumer and electronics industries. Previously, she has served as the Quality and Regulatory lead at Kangaroo Design, Thornhill Research Inc. and Z-Tech Canada Inc., where she led these innovative medical device firms through their initial ISO 13485 registration process and obtained EU, FDA and Health Canada approvals for their products. She is a member of the American Society of Quality (ASQ) where she achieved a Certified Manager of Quality (CQM) certification in 2011 and actively maintains her ASQ Certified Biomedical Auditor (CBA) certification.