Medical Device Regulatory Affairs, Quality Auditing, Compliance, and CER Support for your company while subscribing to the least burdensome approach.
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Nosotros hablamos español. Falamos portugues.
Regulatory and Quality Assessments and FDA Warning Letter and 483 Support
Allow us to Assess your Regulatory and Quality needs per ISO 13485 and FDA 21 CFR 820 Quality Systems Regulation
Quality Auditing, Audit Prep, and ISO 13485 : 2016 Gap Analysis, MDSAP, Internal Audit, External Audit Support and Remediation
Allow us to Audit your Quality System, prepare you for your next external audit, and support you during your next external audit by FDA, Registrar, Notified Body, ANVISA, or Other Authorities
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. Clinical Evaluation Report (CER).
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.