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?
- Trusted by 500+ manufacturers world wide
- Established regulatory consultancy since 2017
- Support across EU, UK and global compliance
- Medical Devices, IVDs, Cosmetics and PPE
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 ConsultationFind the right Patient Guard Service
Complete this short form and our team will review your enquiry and identify the most suitable support for your product, project, or regulatory need
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
FDA QMSR and ISO 13485: What Medical Device Manufacturers Need to Know in 2026
FDA’s Quality Management System Regulation (QMSR) is now in effect. This guide explains how QMSR incorporates ISO 13485:2016, what FDA-specific requirements remain, how FDA inspections have changed and what medical device manufacturers need to do to maintain US compliance.
MHRA Confirms Indefinite Recognition of CE-Marked Medical Devices in Great Britain
The MHRA has confirmed plans to recognise CE-marked medical devices indefinitely in Great Britain, removing the planned 2030 deadline for qualifying EU MDR and IVDR devices. Discover what this significant regulatory announcement means for manufacturers, UKCA marking, UK Responsible Person requirements and future access to the UK medical device market.
FDA Medical Device Classification: Class I, Class II and Class III Explained
Understand FDA medical device classification and the differences between Class I, Class II and Class III devices. Learn how to identify your FDA product code, regulatory controls, 510(k) exemptions and the appropriate pathway to the US market.
FDA 510(k) Clearance: A Step-by-Step Guide for Medical Device Manufacturers
Does your medical device require FDA 510(k) clearance? This step-by-step guide explains the 510(k) process, substantial equivalence, predicate devices, testing, eSTAR submissions, FDA review and what manufacturers need to do after clearance.
FDA Medical Device Regulations: A Complete Guide for Manufacturers
Planning to place a medical device on the US market? This complete guide explains FDA medical device regulations, including device classification, 510(k), De Novo and PMA pathways, QMSR and ISO 13485, establishment registration, device listing, U.S. Agent requirements, UDI and post-market obligations.
How to Become NHS Procurement Ready: From DTAC to NHS Market Access
Preparing to sell digital health technology to the NHS requires more than completing DTAC. This guide explains how manufacturers can build a procurement-ready position by aligning regulatory compliance, clinical safety, data protection, cybersecurity, interoperability, accessibility and commercial evidence for NHS market access.
