Tom Smestad is the principal of Smestad & Associates LLC.\u00a0 Mr. Smestad has over 30 years of experience in the design, development and regulation of medical products.\u00a0 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.\u00a0 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.\u00a0 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.\u00a0 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.\u00a0 In 1994, he was recruited to manage the development of XOMA Corporation’s lead compound for treatment of sepsis.\u00a0 From 1977 to 1994, Mr. Smestad held positions of increasing responsibility in project management, product development, quality control and manufacturing at Collagen Corporation.\u00a0 He holds a B.S. degree in chemistry from University of California, Santa Barbara.<\/p>\n
Our Team<\/p>\n
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.<\/p>\n","protected":false},"excerpt":{"rendered":"
Tom Smestad is the principal of Smestad & Associates LLC.\u00a0 Mr. Smestad has over 30 years of experience in the design, development and regulation of medical products.\u00a0 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.\u00a0 Mr. Smestad’s […]<\/p>\n","protected":false},"author":1,"featured_media":11,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/6","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.smestad.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=6"}],"version-history":[{"count":9,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/6\/revisions"}],"predecessor-version":[{"id":110,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/6\/revisions\/110"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/media\/11"}],"wp:attachment":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=6"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}