Dallas L. Thomas, RAC, MHA, MPA, SSYB
Dallas L. Thomas, RAC, MHA, MPA has 14 years’ experience in the medical device industry in the areas of regulatory affairs, quality management systems, compliance, auditing, and clinical evaluation. Dallas works on activities associated with FDA submissions, particularly 510(k), Emergency Use Authorizations, FDA Enforcement Policies, FDA Establishment Registration, UDI, GUDID, CE Marking per EU MDR 2017/745 maintaining regulatory approvals, compliance to ISO 13485:2016, MDSAP Audits, Internal Audits, Gap Audits, Supplier Audits, FDA regulatory and quality support, and European regulations among other international market authorizations of products, and clinical evaluation reports (CERs). His qualifications include Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society, Certified Lead Auditor for ISO 13485 issued by BSI, and is a Six Sigma Yellow Belt. He also brings his education to our team with a Bachelor’s in Human Development, Masters’ of Healthcare Administration, and Masters of Public Administration. He has experience working with multi-disciplinary teams supporting product development and product sustaining. Dallas also brings exposure to national & international regulatory standards such as the new EU Medical Device Regulation (MDR), Good Manufacturing Practices (GMPs), ISO 13485, ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185 (ANVISA in Brazil), MDD 93/42/EEC, and Latin America regulations among others. Dallas also bring his multilingual skills to our team, as he is fluent in Portuguese and Spanish, and has lived abroad in Latin America in the past.