Medical Device Regulatory Compliance
UKRP, EU Rep, AU & US-FDA
QA Training
EU Authorized Representative (EU Rep)
Get MDR-compliant CE Marking and EU registration
UK Responsible Person (UKRP)
Register your device with MHRA quickly and cost-effectively.
FDA US Agent
Obtain your 510(k), meet 21 CFR Part 807 requirements and start selling in USA
Australian Sponsor
Open to a new place full of opportunities
under similar EU regulations
AF Pharma has been providing regulatory compliance solutions for over 14 years, helping medical device manufacturers enter markets across Europe, North America, and Australia. We specialize in UK Responsible Person (UKRP), EU Authorized Representative (EU Rep), FDA US Agent, ISO 13485 certification support, and quality-regulatory training. Our cost-effective, fast-track solutions simplify market entry, ensure compliance with the latest regulations, and provide essential training for teams to bring new products to the world!
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✅ Main Regulatory Services for Medical Devices
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UK Responsible Person (UKRP) → MHRA approval and UKCA Marking.
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EU Authorized Representative (EU Rep) → EU registration and MDR / IVDR certifications.
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FDA US Agent → 510(k) and FDA Registrations
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ISO 13485 & QMS Consulting → Prepare your Quality Management System for an international certification and get certified today!
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Market Access Strategy → Accelerate your device approval in the EU, UK, US & Australia.
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​📩 Need help with regulatory compliance? Contact us today!​
AF Services
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Global Regulatory Representation – UKRP, EU Rep & FDA US Agent
AF Pharma provides expert representation services for medical device manufacturers. We ensure regulatory compliance in global markets by acting as your:
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EU Authorized Representative (EU Rep) for MDR & IVDR compliance.
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UK Responsible Person (UKRP) for MHRA registration.
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FDA US Agent for 510(k) & De Novo submissions.
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Person Responsible for Regulatory Compliance (PRRC) for EU requirements.
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Australian Sponsor for TGA registration & ARTG listing.
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Quality & Certification – ISO 13485 & FDA Compliance
Ensure compliance with ISO 13485 & FDA quality standards. We help medical device manufacturers:
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Implement & certify ISO 13485 Quality Management Systems (QMS).
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Prepare for FDA audits & inspections.
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Align with EU MDR & IVDR post-market surveillance requirements.
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Achieve regulatory certification with faster approval times.
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Regulatory Documentation – MDR, IVDR & FDA Submissions
AF Pharma specializes in regulatory documentation for medical devices. Our services include:
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MDR & IVDR Technical Files for CE Marking.
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FDA 510(k), De Novo & PMA submissions for the US market.
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UKCA & MHRA documentation for UK compliance.
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Clinical Evaluation Reports (CER) & Post-Market Surveillance (PMS) plans.
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Regulatory gap analysis to ensure full compliance.
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Amazon certifications and Amazon Responsible person
AF Pharma supports manufacturers with Amazon requirements. Our services include:
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Amazon Responsible Person
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Amazon designated
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Amazon certifications
This is for all products, not only Medical Devices!
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Training
AF Pharma supports startups and new developments by training professionals to become experts!
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General training
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Lead auditor
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Experts in EU and USA regulations
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Onsite or Remote
CONTACT US
Barcelona, Spain | London, England | Orlando, US
+34 648 988915 | +44 7862 223321 | +1 689 247 1190