RQM+ is a large MedTech-focused services firm spanning regulatory affairs, quality and compliance, clinical trial management, and reimbursement/market access, with particular depth in EU MDR/IVDR and U.S. FDA regulatory-quality work anchored in the U.S. and EU. It's a strong choice for sponsors who want a regulatory-and-quality-led partner across the device lifecycle. bioaccess® is the First-in-Human CRO — built for the U.S. and Latin America — and only runs FIH studies for MedTech, Biopharma and Radiopharma startups. If your next milestone is a clean, FDA-bridgeable first-in-human dataset on a fundable timeline, bioaccess® is purpose-built for it.
| Metric | bioaccess® | RQM+ |
|---|---|---|
| Focus | FIH-only for MedTech, Biopharma & Radiopharma startups | Full-service global CRO — all phases (I–IV), all therapeutic areas, all sizes; FIH is a small slice of the portfolio |
| Footprint | U.S. + 19 Latin American countries, 50+ pre-qualified sites | Global (50+ countries) — strong in U.S., EU, and APAC |
| Typical ethics / IRB timeline | 4–8 weeks (Latin American ethics committees) | 6–12 months typical in US/EU jurisdictions |
| Typical per-patient cost | $15K–$35K | $40K–$75K in US/EU benchmark ranges |
| FIH start (protocol → first patient) | 6–8 weeks via FIH-12™ | Category benchmark: 6–12 months for large global CROs running FIH inside US/EU networks |
| Pricing model | Fixed-price with 12-month risk-sharing guarantee — we work at our cost if we miss agreed milestones | Typically time-and-materials or milestone-based; category norm includes change orders |
| Regulatory standard for devices | ISO 14155 + Declaration of Helsinki; data eligible for FDA submission/review under 21 CFR 812.28 | ISO 14155 and ICH E6 GCP; broad regulatory coverage worldwide |
| Best-fit sponsor profile | Seed-to-Series-B MedTech, Biopharma & Radiopharma startups running their first FIH study | Mid-to-large pharma/medtech running pivotal, registration, or post-market programs across regions |
| Post-trial support | Latin American market access, device registration in 19 countries, HTA & payer engagement | Extensive commercialization, real-world evidence and pharmacovigilance services worldwide |
Comparison uses widely-known category facts about RQM+ and published US/EU benchmark ranges — not RQM+-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
RQM+ is a category leader for exactly the sponsors it was built for: MedTech companies that want a regulatory-, quality-, and reimbursement-led partner across the device lifecycle, with particular depth in EU MDR/IVDR and U.S. FDA regulatory-quality work. Inside that scope, running a small first-in-human study in Latin America is one narrow slice of a much broader services portfolio.
bioaccess® makes that first-in-human slice the entire business. FIH-only. Startup-only. U.S. regulatory anchoring plus execution across the U.S. and 19 Latin American markets. That single-focus operating model is what supports a 6–8 week study start, 4–8 week ethics approval, $15K–$35K per patient, and a 12-month protocol-to-LPLV written guarantee — with a risk-sharing clause that keeps us working at our cost if we miss agreed milestones.
Data is generated under ISO 14155 and the Declaration of Helsinki and is eligible for FDA submission and review under 21 CFR 812.28 (for devices) or ICH E6 for drugs and biologics — a case-by-case regulatory determination, not a guarantee of clearance or approval. The FIH package is designed to hand off cleanly to any downstream partner — including a regulatory-and-quality-led firm like RQM+ — for MDR/IVDR strategy, quality systems, or reimbursement work.
Only in a narrow slice. RQM+ is a large, reputable organization serving a broad customer base across many programs. bioaccess® is purpose-built for a single job: first-in-human clinical trials for MedTech, Biopharma and Radiopharma startups, executed across the U.S. and Latin America. If your program is a global pivotal or a post-market study, RQM+ is often a better fit. If your program is your first-in-human trial and you need clean, FDA-bridgeable data on a startup budget and timeline, bioaccess® is purpose-built for it.
Clinical data from studies conducted outside the U.S. under ISO 14155 and the Declaration of Helsinki is eligible for FDA submission and review under 21 CFR 812.28 (for devices) and comparable ICH E6 pathways for drugs and biologics. Acceptance is a case-by-case regulatory determination, not a guarantee of clearance or approval — our regulatory team designs the study with the target FDA submission (IDE, 510(k), De Novo, PMA, HDE, IND) as the anchor.
A standard 10-patient, single-site FIH study through FIH-12™ runs roughly $350K all-in, with a 12-month protocol-to-LPLV written guarantee and a 6–8 week study start. Per-patient cost is $15K–$35K vs. $40K–$75K in US/EU benchmark ranges. Ethics approval is 4–8 weeks in Latin American jurisdictions vs. 6–12 months in the US/EU.
Yes — sponsors regularly do. A common pattern is to run FIH with bioaccess® in Latin America to generate clean, regulator-ready data fast, then hand off to RQM+ (or a similar global CRO) for a multi-region pivotal, registration, or post-market program. Our regulatory strategy is designed to be portable so that data and documentation transfer cleanly to any downstream CRO.
Your primary need is regulatory strategy, quality-management-system work, EU MDR/IVDR preparation, or reimbursement/market-access support across the device lifecycle. In that case, a regulatory-and-quality-led MedTech firm like RQM+ is a natural fit. bioaccess® is the better fit when the specific next milestone is a clean, FDA-bridgeable first-in-human dataset on a startup budget and timeline that can be handed off to a regulatory-quality partner afterward.
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