RQM+ describes itself as “The MedTech CRO”, a full-service partner spanning regulatory and quality, clinical trials, lab and material science (via Jordi Labs), and reimbursement, with particular depth in EU MDR/IVDR and U.S. FDA regulatory-quality work, headquartered in Cary, North Carolina, with a European HQ in the UK. 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 Americas — and only runs FIH studies for MedTech and Biopharma startups, and supports radiopharmaceutical and theranostics first-in-human and early feasibility trials. 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 and Biopharma startups, with radiopharma trial support | MedTech-only CRO (“The MedTech CRO”): regulatory and quality, clinical trials, lab and material science (Jordi Labs) and reimbursement, from concept to post-market; added first-in-human study expertise with its 2023 acquisition of Libra Medical |
| Footprint | U.S. + 19 Latin American countries, 100+ sites | Offices in the U.S. (Cary, NC HQ; Jordi Labs in Mansfield, MA), the U.K. (European HQ), Switzerland and Germany; cites regulatory submissions across the U.S., Europe and the U.K. |
| Typical ethics / IRB timeline | Varies by study; we confirm per protocol (Latin American ethics committees) | Not published by RQM+ |
| Typical per-patient cost | See sample budget | No published US/EU comparison |
| FIH start (protocol → first patient) | Varies by study via FIH-12™; we confirm per protocol | Not published by RQM+ |
| Pricing model | Fixed-price with 12-month risk-sharing guarantee — if we miss the protocol-to-LPLV timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV | 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 | Regulatory and quality, reimbursement and post-market support across the device lifecycle |
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 anywhere from Canada down to Argentina. That single-focus operating model is what supports a timeline that varies by study (we confirm it per protocol) from protocol to first patient, study-specific ethics approval, a study-specific budget quote, and a 12-month protocol-to-LPLV written guarantee — with a risk-sharing clause: if we miss that timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV.
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 and Biopharma startups, with support for radiopharmaceutical and theranostics trials, executed across the Americas. 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.
FIH-12™ comes with a 12-month protocol-to-LPLV written guarantee and first-patient timing varies by study (we confirm it per protocol). Budget depends on study design; we provide a study-specific quote. Ethics approval is 4–8 weeks in Latin American jurisdictions vs. a timeline that varies by study (we confirm it per protocol) 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.
All CRO comparisons · First-in-Human CRO · Clinical Trials in Panama · Book a free 30-min strategy call