Speak with a Regulatory Expert
Get expert support with EU MDR, IVDR, UKCA, cosmetics, PPE and global regulatory compliance. Tell us about your product or project, and one of our specialists will contact you within 24 hours.
How can we help you?
Select the area most relevant to your product or regulatory needs.
Medical Devices
EU MDR and UKCA support
In Vitro Diagnostics (IVD)
IVDR and FDA 510(k) support
Cosmetics
EU and UK cosmetic compliance
Personal Protective Equipment (PPE)
EU and UK PPE compliance
Quality Assurance
ISO 13485, ISO/IEC 27001 ISO 9001 support
FDA Submissions
US regulatory strategy and submissions
Request a Quote or Book a Consultation
Tell us about your product and regulatory requirements, and one of our specialists will contact you within 24 hours.
Why contact Patient Guard?
2. A specialist contacts you within 24 hours
3. We arrange a consultation if needed
4. You receive clear next steps
Book a free 30-minute consultation with one of our regulatory experts.
Book a Free ConsultationRequest a Quote or Speak with a Regulatory Expert
Tell us about your product and regulatory requirements, and one of our specialists will contact you within 24 hours.
Our Locations
Patient Guard Ltd
Lancaster House Amy Johnson Way, Blackpool, Lancashire, FY4 2RP. United Kingdom
Company Registration Number: 10654752
Patient Guard Europe UG (haftungsbeschränkt)
Hauffstraße 41, 73765, Neuhausen, Deutschland (Germany)
Company Registration Number: HRB 779309
Supporting EU Market Access via our Germany-based Authorized Representative services.
EUDAMED Authorised Representative SRN: DE-AR-000007523
EUDAMED Importer SRN: DE-IM-000025621
Frequently Asked Questions (FAQs)
How quickly can Patient Guard support a BSI ISO 13485 audit?
Our internal Quality Management team recently led Patient Guard through a successful BSI certification. Depending on your current documentation state, we can typically perform a Gap Analysis within 2–3 weeks to prepare you for Notified Body scrutiny.
Do you provide support for both UKRP and EU Authorised Representative services?
Yes. With physical offices in both Blackpool (UK) and Neuhausen (Germany), we provide seamless dual-market access, acting as your legal representative for both the MHRA and EU Notified Bodies.
Can you help with Clinical Evaluation Reports (CER) for the MDR?
Absolutely. Our clinical specialists are BSI-trained in MDR Clinical Evaluation and IVDR Performance Evaluation. We ensure your technical files meet GSPR requirements and ICH GCP standards for clinical data.
Does your team handle specialized Biocompatibility and Cybersecurity requirements?
Yes. We have in-house expertise in ISO 10993 (Toxicology) and a Lead Auditor for ISO 27001 (Information Security). This integrated approach is essential for modern Software as a Medical Device (SaMD) and high-risk hardware.
Can you help with IVDR Performance Evaluation and Technical Documentation?
Yes. Our team is specifically certified by BSI for the In Vitro Diagnostic Regulation (IVDR). We provide comprehensive support for Performance Evaluation Reports (PER), Scientific Validity, and Analytical/Clinical Performance, ensuring your IVD products meet the rigorous 2026-2027 compliance deadlines.
Do you offer toxicology assessments for ISO 10993 Biocompatibility?
Absolutely. Led by our toxicology and biocompatibility specialist, Steve Condie, we provide expert guidance on ISO 10993-1 testing strategies. We help manufacturers avoid over-testing while ensuring chemical characterization and biological safety requirements are fully satisfied for global submissions.
News from Patient Guard
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Patient Guard’s QMS Achieves ISO 13485 Certification
A milestone that strengthens our commitment to quality
Regulatory and quality consulting is one thing. Building, implementing, and passing audits on your own Quality Management System is another.
UDI Medical Devices: Types Explained (EU MDR Guide)
UDI medical devices are not just a labelling requirement. They are the backbone of traceability under EU MDR.
EUDAMED Enters a New Phase: Are You Ready for May 2026?
EUDAMED enters a new phase as four modules become mandatory from 28 May 2026. Learn what changes and how to prepare for compliance.
ISO 14971 Risk Management Implementation Guide
Medical devices exist to improve health outcomes, but every device carries potential risk. Managing those risks in a structured, documented, and defensible way is essential for regulatory approval and patient safety.
Clinical Evaluation Report: EU MDR Requirements
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
