Medical Device Regulatory Services — Global Compliance, Simplified
RABT Global is a specialist regulatory consulting for medical devices firm delivering end-to-end device regulatory services across FDA, EU MDR/IVDR, UK MHRA, ISO 13485, and global market entry programmes.
Expert medical device submission services and regulatory consulting across every major market. Let’s review your device pathway today.
Medical device regulatory services are the cornerstone of any successful market entry strategy for device manufacturers worldwide. The regulatory landscape for medical devices is among the most demanding in life sciences — with regulations on medical devices constantly evolving across the FDA, EU MDR, UK MHRA, and GCC regulatory bodies. A single misstep in your medical devices regulatory compliance programme can result in submission rejection, product recall, or loss of CE marking.
At RABT Global, our medical device regulatory services span the complete device lifecycle — from initial device classification and regulatory strategy through to submission preparation, market approval, and post-market surveillance. As a specialist regulatory consultant for medical devices, our team has deep expertise in all major device regulatory frameworks and device types — from in vitro diagnostics and SaMD to Class III implantables and combination products.
Our medical device regulatory consulting services are designed to give device manufacturers the confidence to navigate complex regulatory requirements efficiently, with a clear pathway to approval in every target market. Whether you need medical device submission services for a single market or a coordinated global medical devices regulatory affairs programme, RABT Global is your specialist regulatory partner.
Our Medical Device Regulatory Services — By Framework
| Regulatory Framework | RABT Global Services |
|---|---|
| FDA (USA) — 21 CFR 820 | 510(k) submission, PMA, De Novo, US FDA Agent, IDE support |
| EU MDR 2017/745 | CE marking, technical documentation, CER, EUDAMED, NB liaison |
| EU IVDR 2017/746 | IVDR classification, performance evaluation, NB audit support |
| UK MHRA | UKCA registration, post-Brexit device compliance, MHRA liaison |
| ISO 13485:2016 | QMS gap analysis, implementation, MDSAP alignment, audit prep |
| GCC / Middle East | UAE MOHAP, Saudi SFDA, Kuwait MOH device registration |
| India CDSCO | Class A–D device registration, MD-14 application support |
| Australia TGA | ARTG inclusion, Class I–IV device registration support |
End-to-End Device Regulatory Services
Comprehensive medical device regulatory consulting across the full product lifecycle.
Device Classification & Regulatory Pathway Assessment
FDA class, EU MDR/IVDR class, UKCA, and global device classification
CE Marking Consulting
Technical documentation, conformity assessment, Declaration of Conformity, NB selection support
FDA 510(k) Submission Services
Predicate strategy, dossier preparation, Q-Sub management, FDA response handling
EU MDR/IVDR Compliance
Full EU MDR and IVDR technical documentation, CER, PMS, EUDAMED registration
ISO 13485 QMS Consulting
QMS design, implementation, gap analysis, and MDSAP alignment
Clinical Evaluation Reports (CER)
EU MDR-compliant CER preparation, PMCF planning, SSCP preparation
Post-Market Surveillance (PMS)
PMS plans, PMSR/PSUR preparation, vigilance reporting, FSCA management
EU Authorised Representative Services
Statutory EU MDR/IVDR authorised representative services for non-EU manufacturers
US FDA Agent Services
US Agent appointment under 21 CFR 807.40 for foreign device manufacturers
What are Medical Device Regulatory Services?
Medical device regulatory services are specialist professional services that help medical device manufacturers obtain and maintain regulatory approvals across global markets. These services cover device classification, regulatory strategy, CE marking (EU MDR/IVDR), FDA 510(k) and PMA submissions, ISO 13485 quality management, post-market surveillance, EU Authorised Representative, and US FDA Agent services — provided by specialist regulatory consultants like RABT Global.
Medical Device Regulatory Services — FAQs
For the EU market under EU MDR 2017/745, you will need: device classification, technical documentation preparation (Annexes II & III), Clinical Evaluation Report (CER), Post-Market Surveillance plan, EUDAMED registration, UDI assignment, Declaration of Conformity, and an EU Authorised Representative (for non-EU manufacturers). RABT Global provides all of these as part of our CE marking and EU MDR compliance services.
A 510(k) (Pre-Market Notification) is required for most Class II devices and demonstrates substantial equivalence to a legally marketed predicate device. A PMA (Pre-Market Approval) is required for Class III devices and involves a more rigorous review of safety and effectiveness data. RABT Global provides both FDA 510(k) submission services and FDA PMA advisory services.
Yes. If you are a non-EU/EEA medical device manufacturer placing CE-marked devices on the EU market under EU MDR 2017/745, you are legally required to appoint an EU Authorised Representative. RABT Global provides EU Authorised Representative services for medical device manufacturers across all device classes.
Yes. Our end-to-end device regulatory services include multi-market submission coordination — managing FDA, EU MDR, UK MHRA, and GCC submissions in parallel to accelerate your global market entry timeline. We provide a single project management interface across all your target markets.
Navigate Medical Device Regulations with Confidence — Partner with RABT Global
Expert medical device regulatory services across FDA, EU MDR, UK MHRA, and global markets. End-to-end device regulatory compliance from a single trusted partner.