Heather Crawford has over 20 years of experience in the medical device industry, specializing in regulatory affairs and quality management systems. Heather’s background includes developing or contributing to 25+ Clinical Evaluation Reports, 25+ EU Technical Files/Design Dossiers, US Premarket Approval (PMA) applications, and 25+ US 510(k) submissions. Heather also has extensive experience in standards development and contributed to the US position on standards, including ISO 13485 and ISO 9001. As a Senior Quality and Regulatory Affairs Consultant, Heather works directly with clients on their quality and regulatory projects. She also peer reviews reports and regulatory filings for her colleagues. Prior to joining Emergo by UL, Heather worked in industry, focusing on implantable devices and new products.