Welcome to The Regulatory Resource (TRR).

Trusted Expertise in Medical Device Regulatory Affairs, Clinical Medical Writing, & Quality Systems

Welcome to The Regulatory Resource (TRR), where expert regulatory strategy meets global market access for medical devices of all types. Our consultants come from various clinical areas in the medical device industry. TRR delivers precise, efficient consulting in medical device submissions, quality systems, and clinical medical writing.

With over 16 years of hands-on experience, TRR supports:
• US FDA Submissions: 510(k), PMA, IDE, Pr-Submissions and US Agent Services
• EU MDR 2017/745 CE Marking and Clinical Evaluation Reports (CERs)
• Quality Systems: ISO 13485:2016, 21 CFR 820 QSR, MDSAP compliance, Mock Audit, Audit Defense

• External Audits: Supplier Audits, FDA Inspections, Notified Body Audits, Unannounced Audits
• Medical Literature reviews and post-market surveillance (PMS/PMCF)

TRR has partnered with over 50 clients—from startups to global leaders like Medtronic, Integra, and Bausch & Lomb, Terumo, and other medical device manufacturers of all sizes, by providing results-driven support for devices in various clinical sectors including, dental, ophthalmic, neurovascular, biosensor, surgical instruments, disposables, cardiovascular, PPE, gastrointestinal, vascular access, software as a medical device, and implantable devices among various medical device sectors, with our expertise in Regulatory Submissions, Clinical Medical Writing, and Quality Management Systems compliance.

Based in both Miami Florida, USA and Orlando Florida, USA, TRR is well positioned to attend to your medical device needs. Contact us today via mobile or Whatsapp at +1 435 258 8221 or via email at Thomas.Regulatory@gmail.com

See our Full List of Services HERE.