About Us

Tom Smestad is the principal of Smestad & Associates LLC.  Mr. Smestad has over 30 years of experience in the design, development and regulation of medical products.  He has over 15 years experience as an independent consultant to medical device companies in the areas of regulatory affairs, quality assurance, product design and development.  Mr. Smestad’s experience encompasses product development strategies, compliance auditing, project management and major regulatory filings including 510(k)s and design dossiers for medical device CE marking.  His experience enables him to develop and implement quality systems and validation programs to ensure compliance with regulatory requirements including FDA regulations, ISO 13485 and the Medical Device Directive.  Mr. Smestad held the position of Vice President of Manufacturing at ReGen Biologics from 1996 to 2000 where he was responsible for the development and manufacture of an implantable meniscus replacement.  In 1994, he was recruited to manage the development of XOMA Corporation’s lead compound for treatment of sepsis.  From 1977 to 1994, Mr. Smestad held positions of increasing responsibility in project management, product development, quality control and manufacturing at Collagen Corporation.  He holds a B.S. degree in chemistry from University of California, Santa Barbara.

Our Team

Smestad & Associates LLC draws on a network of consultants who are subject matter experts. We match our consultants’ expertise to suit the client’s needs.