Founded in 2001, Lincé Consulting has focused on delivering top quality, responsive medical product consulting services to all its clients. We truly believe in closely partnering with our customers and establishing excellent relationships so that we deliver what they need to meet their strategic objectives.
Lincé Consulting is an expanding group of professionals with over 350 years of combined experience who partner with our clients to achieve their regulatory, quality and clinical goals in all different capacities based on the client’s infrastructure and needs.
When you have a problem that needs to be addressed, our management team identifies either a specific individual or a group of experts from its consultant database. Experts are selected to match their skills and knowledge with your requirements. This means we have a seasoned team of professionals on hand, available and fully capable of addressing any regulatory, clinical or quality need your company may have.
Nancy M. Lincé, President and CEO
Nancy has over 30 years of experience in regulatory, clinical and quality affairs spanning a broad range of technologies including innovative medical device, combination and drug delivery products. She has written or overseen over 400 regulatory submissions (PMA, De Novo, 510k, Pre-Sub/IND, IDE, IND, NDA, Design Dossiers/Technical Files, and various global applications), has extensive experience negotiating and interacting with FDA and international regulatory agencies to obtain clinical and marketing clearances/approvals, and has developed and executed regulatory, clinical and quality strategies for a wide range of products, technologies and applications resulting in significant cost savings and decreased time to market. Nancy is the founder and President/CEO of Lincé Consulting, LLC, a consulting organization focused on delivering top quality, responsive regulatory, clinical and quality consulting services to a variety of clients ranging from small start-up companies to large established corporations. Lincé Consulting, LLC is an expanding group of professionals with over 350 years of combined experience working in the field of innovative medical product development, leading and supporting clients in securing regulatory approvals to investigate and market their medical products worldwide in the most efficient manner possible, while maintaining regulatory and quality compliance. Areas of focus include Regulatory, Clinical and Quality proficiencies in various medical disciplines and applications, including but not limited to: General Surgery/Laparoscopy; Gynecology/Infertility; Gastroenterology; Urology; Cardiac Surgery; Cardiology; Orthopedics; Oncology; Diabetes, Vascular Closure; Coronary, Peripheral and Neuro Vascular Disease; Embolic Protection; Various Imaging Technologies; Dental; Women's Health; ENT; Wound Care; Biometric Monitoring; Trans-dermal Drug Delivery; Combination Products; various IVDs and many more. Lincé Consulting, LLC is well versed in the myriad of Regulatory, Clinical and Quality requirements and compliance conditions applied to medical products worldwide, and the team is dedicated to establishing the most practical solutions to meet client milestones in the most efficient and cost-effective way possible, from concept through post-marketing.
Prior to founding Lincé Consulting, LLC in 2001, Nancy was Vice President, Clinical and Regulatory Affairs at Eclipse Surgical Technologies, Inc., focused on laser and fiberoptic cardiac surgery devices, where she was responsible for the definition and execution of global clinical and regulatory strategies required to gain and maintain regulatory approvals worldwide. At Conceptus, Inc., a women’s health medical device company focused on infertility and contraception, Nancy prepared and managed regulatory submissions, participated in extensive FDA negotiations, and managed global clinical study efforts. At Origin Medsystems (Eli Lily and later Guidant), focused on laparoscopic, cardiac surgery and cardiovascular applications, Nancy managed the international regulatory efforts and defined and integrated international standards into product development and manufacturing processes resulting in streamlined global marketing approvals. She is a member of the Regulatory Affairs Professional Society (RAPS), received her Regulatory Affairs Certification (RAC), holds a B.Sc. in Business Management and has been a regulatory coach for the Stanford Biodesign Innovation program for the last 7 years.