Lynn Bougie

Lynn Bougie, Vice President of Quality and Management Representative has over 15 years of multi-functional medical device experience across a range of start-ups and larger corporations. Her roles in quality assurance, regulatory affairs and project management have defined and promoted a quality atmosphere across MMS. As VP of Quality and Management Representative, Lynn has developed and scaled the quality management system to support each phase of growth for MMS. Her guidance provides the MMS team confidence in delivering high quality products in compliance with regulatory requirements.

Lynn’s leadership roles across multi-functional teams working to design, develop, and manufacture new and innovative medical technologies has led her to bring high-quality products to market from early concept to first human use and commercial release. Lynn’s experience spans across cardiovascular, neurovascular, gynecology, gastroenterology, colorectal, spinal, endoscopy, and airway devices. She has been responsible for implementing, obtaining certifications, and maintaining quality management systems and associated device design and manufacturing records in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR and other regulations. She has participated in preparation of regulatory submissions for clinical studies, FDA 510(k) and De Novo, and EU technical documentation for CE Mark. She is responsible for successfully representing and leading the MMS team through notified body audits and FDA inspections.

Prior to joining MMS, Lynn served as the Director of Quality at several medical device companies including Iogyn, acquired by Boston Scientific, and Pelvalon, Inc., acquired by Laborie.

Lynn has a BS in Mechanical Engineering from Northeastern University.