Quality, Regulatory, Auditing and Compliance Support for your company
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Regulatory and Quality Assessments
Allow us to Assess your Regulatory and Quality needs.
Quality Auditing, Audit Prep, and Audit Support
Allow us to Audit your Quality System, prepare you for your next external audit, and support you during your next external audit.
Regulatory Submissions and Registrations
510(k) Submissions to FDA, Pre-subs, Establishment Registrations, Device Listings, UDI, International Registrations (Latin America, Asia, Eastern Europe, Middle East), EU CE Marking and Tech File/Design Dossier Creation and Maintenance.
Read what people have said
Dallas is very detail oriented. He is well organized and exceptional at documentation and follow up. He is self motivated and also functions extremely well working with teams. He looks to the future and is always looking at ways to improve both himself and whatever process he is working on. The thing that impresses me the most about Dallas is his ability to translate. He can effectively carry on bilingual conversations, while translating, without slowing the conversation at all. He is an exceptional asset to anyone looking to do business in Latin America. While I had the opportunity to work with Dallas, he handled all regulatory responsibilities for most of Latin America, Australia and all of EEA. He will be an asset to any company who is fortunate enough to work with him.