Michaela Shaw is a regulatory consultant with 15 years of experience within the medical device industry, leading a variety of start-up companies 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. She is the founder of Shaw Quality Solutions, guiding clients through certification and management of ISO13485 and FDA compliant Quality Management Systems, and regulatory submissions for market approvals in US, Canada, Europe, Australia and Asia.