Global Medical Device Regulatory Expertise — CE Marking, FDA & Beyond
RABT Global is a specialist medical device regulatory consulting firm providing end-to-end device regulatory services — FDA 510(k), CE marking under EU MDR, UK MHRA, ISO 13485, and GCC registration — for device manufacturers worldwide.
Tell us your device and your target markets — we’ll map your fastest, most cost-effective route to approval.
Medical device regulation is moving faster — and getting stricter — than ever. EU MDR and IVDR have rewritten what it takes to keep a device on the market in Europe, and FDA expectations for Quality, clinical evidence, and post-market surveillance continue to rise.
RABT Global delivers specialist device regulatory support across every major framework — FDA, EU MDR/IVDR, UK MHRA, ISO 13485, and GCC — under a single accountable team.
From classification through post-market vigilance, we help manufacturers enter and stay in their target markets with confidence.
Our Medical Device Regulatory Services — By Region
Dedicated regional teams covering every major medical device regulatory framework.
USA — FDA
- FDA 510(k) Submission
- FDA PMA Services
- De Novo Classification
- US FDA Agent Services
- FDA Device Classification
Europe — EU MDR/IVDR
- CE Marking Consulting
- EU MDR Compliance
- EU IVDR Compliance
- Clinical Evaluation (CER)
- Post-Market Surveillance
- EU Authorised Representative
UK — MHRA
- UK MHRA Registration
- UKCA Marking Support
- Post-Brexit Device Compliance
- MHRA Liaison
Middle East — GCC
- UAE MOHAP Registration
- Saudi SFDA Registration
- Kuwait / Qatar / Bahrain / Oman
- GCC MRA Strategy
Lifecycle
Medical Device Regulatory Services — By Lifecycle Stage
From classification to post-market vigilance — a single specialist partner at every stage.
Classification & Strategy
Device classification (FDA/EU MDR/IVDR/MHRA), regulatory pathway selection, pre-submission strategy, and market entry roadmap.
Technical Documentation
510(k) dossier, EU MDR Technical File (Annex II & III), CE technical documentation, and ISO 13485 QMS implementation.
Clinical Evidence
Clinical Evaluation Reports (CER), PMCF plans, equivalence assessment, and literature review strategy.
Submission & Approval
FDA 510(k)/PMA/De Novo filing, CE marking conformity assessment, EUDAMED registration, and health authority liaison.
Post-Market Compliance
Post-Market Surveillance (PMS), PMSR/PSUR reporting, vigilance & FSCA, and lifecycle submission management.
Regulatory Frameworks & Services at a Glance
| Framework / Region | RABT Global Services |
|---|---|
| USA — FDA | 510(k), PMA, De Novo, US Agent, Device Classification |
| Europe — EU MDR/IVDR | CE Marking, MDR/IVDR compliance, CER, PMS, EU Authorised Representative |
| UK — MHRA | MHRA Registration, UKCA Marking, Post-Brexit Compliance, MHRA Liaison |
| Middle East — GCC | UAE MOHAP, Saudi SFDA, Kuwait/Qatar/Bahrain/Oman, GCC MRA Strategy |
| ISO 13485 | Gap analysis, QMS implementation, MDSAP, audit preparation |
| Combination Products | FDA designation, EU MDR borderline, drug-device strategy |
Key Medical Device Services
A curated set of the services manufacturers ask us for most — explore the full 17 below.
FDA 510(k) Submission
Strategy, dossier prep, Q-Sub management, and FDA response handling.
EU MDR / IVDR Compliance
Technical docs, CER, EUDAMED, Notified Body liaison, MDD transition.
UK MHRA Registration
UKCA marking, post-Brexit device registration, MHRA liaison.
GCC Device Registration
UAE MOHAP, Saudi SFDA, Kuwait, Qatar, Bahrain, Oman strategy.
Clinical Evaluation Reports
CER, PMCF plans, SSCP, and literature search support.
Post-Market Surveillance
PMS plans, PMSR/PSUR, vigilance, FSCA, and retainer model.
ISO 13485 QMS Consulting
Gap analysis, QMS implementation, MDSAP, audit preparation.
Combination Products
FDA designation, EU MDR borderline, drug-device strategy.
SaMD / Digital Health
AI/ML devices, clinical decision support, wearables, patient apps.
Device Types Covered by RABT Global
From implantables to AI-driven SaMD — we know your device class and its regulatory nuances.
Implantable
- Orthopaedic implants
- Cardiovascular devices
- Neuromodulation
- Ophthalmic implants
IVD / Diagnostics
- Molecular diagnostics
- Point-of-care testing
- Immunology & serology
- Companion diagnostics
SaMD / Digital Health
- AI/ML-based devices
- Clinical decision support
- Wearable health monitors
- Patient apps (SaMD)
Combination Products
- Drug-device combos
- Biologic-device combos
- FDA jurisdiction strategy
- EU borderline assessment
Why Medical Device Manufacturers Choose RABT Global
End-to-end medical device regulatory services from a single specialist partner — no outsourcing, no fragmentation. Dedicated teams of FDA specialists, EU MDR experts, ISO 13485 consultants, and CER clinical scientists coordinate parallel submissions across FDA, EU MDR, MHRA, and GCC markets, with proactive regulatory intelligence on the rapidly changing device landscape.
Frequently Asked Questions
What medical device regulatory services does RABT Global offer?
End-to-end services across FDA 510(k)/PMA/De Novo, CE marking under EU MDR, EU IVDR, UK MHRA/UKCA, ISO 13485, and GCC device registration — all delivered by dedicated specialist teams.
Do you support Class I–III and IVD Class A–D devices?
Yes. We work across all device classifications including implantables, IVDs, SaMD, and combination products, with regulatory pathways tailored to each class and market.
Can you coordinate parallel submissions in multiple markets?
Multi-jurisdictional coordination is a core strength — we run parallel submissions across FDA, EU MDR, MHRA, and GCC markets to compress your global market entry timeline.
Do you provide EU Authorised Representative and US FDA Agent services?
Yes. We act as your statutory EU MDR/IVDR Authorised Representative and as your 21 CFR 807.40 US Agent, handling ADER and FDA correspondence on your behalf.
Ready to Map Your Global Device Approval Route?
Tell us your device and your target markets — we’ll come back with the fastest, most cost-effective regulatory pathway across FDA, EMA, MHRA, and GCC.