RFG Med, operated by RFG MEDTECH CONSULTING LLC, provides expert regulatory strategy, clinical research support, quality system implementation, and market access consulting for medical technology companies worldwide. Based in Westlake, Ohio.
RFG MEDTECH CONSULTING LLC provides comprehensive consulting services to medical technology companies at every stage of the product lifecycle.
FDA 510(k), PMA, De Novo classification, CE marking under MDR, and global regulatory submissions for medical devices.
ISO 13485, QSR 21 CFR Part 820, CAPA management, internal auditing, and quality management system implementation.
Clinical trial design, investigator-initiated studies, clinical evaluation reports (CER), and post-market surveillance.
Reimbursement strategy, health economics, value proposition development, and market commercialization planning.
Design control, risk management (ISO 14971), usability engineering, and design history file preparation.
International regulatory filings, country-specific registrations, authorized representative services, and global compliance audits.
RFG MEDTECH CONSULTING LLC brings deep regulatory and clinical expertise to help medtech innovators bring life-changing technologies to patients.
Based in Westlake, Ohio, RFG Med (a brand of RFG MEDTECH CONSULTING LLC) is a specialized consulting firm serving the medical technology industry. Our team combines deep regulatory knowledge, clinical research experience, and quality systems expertise to guide medical device companies from concept through commercialization.
We work with startups, established manufacturers, and investors across all major device categories — from Class I through Class III, SaMD, combination products, and IVDs. Our consultants have direct experience at the FDA, notified bodies, and leading medical device companies, giving us a unique perspective on what it takes to succeed in today complex regulatory environment.
At RFG MEDTECH CONSULTING LLC, we believe that expert regulatory guidance should not be a barrier to innovation — it should be a catalyst. We help our clients navigate the regulatory pathway efficiently and strategically, saving time, reducing risk, and accelerating access to patients.
Deep expertise in FDA, EU MDR, and global regulatory frameworks to guide your submission strategy.
Evidence-based approaches to clinical evaluation, study design, and post-market surveillance.
We work as an extension of your team aligned with your business goals and timelines.
Ready to navigate the regulatory pathway? Contact RFG Med for a confidential consultation.