Regulatory Affairs Consulting for Faster Market Approvals
We help manufacturers of medical devices, IVDs and medical device software achieve CE marking, FDA clearance and global registrations, with fixed fees, replies within 4–8 hours and a dedicated team lead on every project.
Regulatory Consulting for Healthcare Technology Manufacturers
From first classification to market approval and beyond, we give manufacturers the technical and regulatory support they need to sell in the USA, the EU, the UK and other markets.
Medical Devices
EU MDR CE marking, FDA 510(k) and registration, technical files, clinical evaluation and ISO 13485 quality systems for Class I to Class III devices.
In Vitro Diagnostics
IVDR CE marking, performance evaluation and testing, and FDA submissions for reagents, analysers, test kits and other IVD products.
Medical Device Software
Software as a medical device (SaMD) classification, life cycle documentation, CE marking and FDA submissions for standalone and embedded software.
We also support drug, food, nutraceutical and cosmetics companies with FDA registration and Drug Master Files.
Why Choose MedDeviceCorp as Your Regulatory Affairs Consulting Firm?
We are committed to exceeding client expectations through excellence in auditing, implementation guidance, documentation and regulatory solutions, with secure control of every document we handle.
Get a Fixed QuoteAbout UsFixed fees, zero surprises
Transparent pricing agreed up front, with no unexpected costs once your project starts.
Replies within 4–8 hours
Every customer query gets a response within 4–8 hours, so your project keeps moving.
Dedicated team lead
One named lead and regulatory consultants assigned to every project from start to finish.
Qualified experts
72 regulatory consultants, including 12 lead auditors and specialists.
Global presence
8 offices and 4 associated offices, serving clients in 13 countries.
Secure document control
Your technical files are shared and stored through secure cloud folders.
Top Regulatory Consulting Services
Everything you need to get your product approved and keep it compliant, handled by one team.
EU CE Marking
CE marking under the EU MDR and IVDR, including technical files and EU representation.
US FDA Consulting
FDA 510(k) submissions, establishment registration and device listing, and US Agent services.
QMS Implementation
Quality management systems that pass certification and meet FDA and international rules.
FDA Audit Support
Preparation before FDA inspections and support with your responses after them.
Country Registrations
Local representatives and product registrations so foreign manufacturers can sell legally.
Clinical and Testing
Clinical evidence, safety testing and post-market activities that regulators expect.
Our Most Requested Services
The three services manufacturers ask us for most, delivered with fixed fees and a dedicated team lead.
CE Marking
Technical documentation, clinical evaluation and notified body support for EU MDR and IVDR CE marking.
View service →510(k) Submission
Predicate selection, testing strategy and a complete 510(k) file prepared and submitted to the FDA.
View service →FDA Registration
Establishment registration, device listing and US Agent services for medical devices, drugs, food and cosmetics.
View service →Professional In-Country Representation Services We Offer
Attention: For foreign importers to Europe, UK and USA.
Regulatory Experience You Can Check
Regulatory Consulting: Frequently Asked Questions
Quick answers about how we work. For anything specific to your device, contact our team.
What does a regulatory affairs consultant do?
We help medical device, IVD and software manufacturers get and keep market approval: classifying the device, preparing technical documentation and submissions such as the CE marking technical file or an FDA 510(k), implementing ISO 13485, and acting as in-country representative.
Which markets do you cover?
The EU (CE marking under MDR and IVDR), the USA (FDA 510(k), establishment registration and U.S. Agent), the UK (UKCA marking and UK Responsible Person) and country registrations in other markets.
How much do your services cost?
Every project has a fixed fee agreed before work starts, so there are no surprises later. See typical MDR consulting fees or ask for a quote for your device.
How quickly will you reply?
We reply to enquiries within 4–8 hours, and every project has a dedicated team lead as your single point of contact.
Can you act as our EU Authorized Representative, UK Responsible Person or US Agent?
Yes. We provide EU Authorized Representative and EUDAMED services, UK Responsible Person and MHRA registration, and U.S. Agent and FDA registration services.
Where are your offices?
We have offices in the USA, India, the UK, Germany, South Korea, Malaysia, Vietnam and Australia. Please book an appointment before visiting; details are on our contact page.
Join 2,589+ manufacturers who already rely on our timely delivery.
Work with the most responsible service provider in regulatory affairs. Tell us about your product and target markets, and get a clear route, timeline and fixed quote.
- Fixed fees
- Replies within 4–8 hours
- Dedicated team lead
- 8 offices worldwide