About Us

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 250 years of combined experience working in the field of medical product development, evaluation and review.

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, RAC, President and CEO

Nancy has over 20 years of experience in regulatory, clinical and quality affairs for medical products. Nancy has written over 160 submissions, has conducted extensive negotiations with FDA and International regulatory agencies, and developed regulatory strategies resulting in significant cost savings and decreased time to market.  Prior to founding Lincé Consulting in 2001, Nancy was Vice President, Clinical and Regulatory Affairs at Eclipse Surgical Technologies, Inc, where she was responsible for the definition and execution of global clinical and regulatory strategies required to gain and maintain regulatory approval worldwide and managed a staff of 18. At Conceptus, Inc., Nancy prepared and managed regulatory submissions, participated in extensive FDA negotiations, and managed clinical study efforts. At Origin Medsystems (Guidant), Nancy managed the international regulatory process and defined and integrated international standards and requirements into product development and manufacturing processes to maintain compliance during a time when the regulatory demands were significantly increasing and changing.  She is a member of the Regulatory Affairs Professional Society (RAPS), received the Regulatory Affairs Certification (RAC) and holds a B.Sc. in Business Management from Merrimack College in Andover, Massachusetts.

 

 

 


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