Expert regulatory affairs and quality assurance consultancy supporting manufacturers through the entire device lifecycle—from classification and clinical evaluation to market access.
Medical device manufacturers must navigate complex regulatory requirements to bring products to market and maintain compliance across multiple jurisdictions.
From EU MDR and UKCA marking to FDA requirements and ISO standards, ensuring compliance can be resource-intensive and technically challenging.
Patient Guard provides expert medical device consultancy services, supporting organisations with regulatory strategy, quality management systems, technical documentation, and ongoing compliance.
We work as an extension of your team, providing practical, hands-on support tailored to your products and business goals.
Whether you are developing a new device, entering a new market, or addressing regulatory challenges, we provide a structured and reliable pathway to compliance.
This page explains Patient Guard’s Medical Device Consultancy services, helping manufacturers navigate regulatory requirements throughout the product lifecycle. If you're looking to understand how regulatory consultants support medical device manufacturers with quality management, Technical Documentation, Clinical Evaluation, Risk Management, CE marking, UKCA marking and global market access, read our Complete Guide to Medical Device Consultancy.
Our team consists of highly experienced regulatory affairs and quality assurance professionals dedicated to simplifying compliance frameworks.
We don't believe in unnecessary administrative bloat. We build practical, efficient systems designed to fit your unique business operations.
From UKCA and CE Marking to FDA submissions, we provide comprehensive strategic pathways to launch your devices in global markets.
Since 2017, hundreds of global medical device and IVD manufacturers have trusted us to secure and maintain their compliance status.
We work as an extension of your team, actively authoring documentation and supporting you all the way through to successful audit completion.
We balance business agility with strict regulatory safety requirements, providing compliance strategies tailored entirely to your device's risk tier.
Our consultancy team is comprised of experienced regulatory professionals with backgrounds in biomedical science, quality assurance, and clinical affairs. We operate out of registered offices in the UK and Germany, offering local compliance capability across Europe and Great Britain. Patient Guard operates under a BSI-certified ISO 13485 Quality Management System.
Developing robust, defined routes to market for UKCA (MHRA), CE Marking (MDR/IVDR), and international global registrations.
Designing, implementing, and maintaining fully compliant QMS frameworks tailored precisely to EN ISO 13485, ISO 9001, and ISO 27001 standards.
Authoring and updating technical documentation to ensure absolute alignment with rigorous Notified Body and regulatory expectations.
Compiling comprehensive Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) utilizing solid evidence streams.
Establishing comprehensive risk files under EN ISO 14971, linking product hazards seamlessly with your active safety and design data.
Setting up proactive PMS loops, PMCF/PMPF plans, and trend tracking architectures to successfully maintain long-term compliance lifecycle safety.
| Stage | What Patient Guard Does |
|---|---|
| Concept & Classification | Determine the correct risk class (Class I, IIa, IIb, III) for your device. |
| Verification & Validation | Advise on testing, biocompatibility, and software validation (SaMD). |
| Market Launch | Register with the MHRA, appoint a UK Responsible Person, or access EU markets. |
| Post-Market Surveillance | Set up PMS, vigilance reporting, and PSUR writing to maintain compliance. |
We provide consultancy across key global regulatory frameworks, including:
We assess your product, regulatory requirements, and current status.
We identify compliance gaps and define a clear action plan.
We support documentation, systems, and regulatory activities.
We ensure your systems and documentation meet regulatory requirements.
We provide continued support for audits, inspections, and updates.
We provide consultancy across all key regulatory and quality areas, including:
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£150 per hour with no hidden fees. Work directly with experienced regulatory consultants and only pay for the time used. Ideal for quick advice, gap assessments, or ongoing project support.
We discuss your requirements, challenges, and define the scope of support needed.
We begin providing guidance, identify key gaps, and outline clear next steps.
Continued consultancy support tailored to your project timeline, priorities, and regulatory needs.
A medical device consultant supports manufacturers with regulatory compliance, quality systems, and documentation required to bring and maintain products on the market.
Ideally at the early stages of product development, but consultancy support can be provided at any stage of the lifecycle.
Yes, we regularly support start-ups with regulatory strategy, CE marking, and QMS implementation.
Yes, we support EU, UK, and US regulatory frameworks.
Support can typically begin within a few days depending on project scope.
Click on the links below to discover more:
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.
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.
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.
For digital health manufacturers preparing to enter the NHS, clinical safety can be one of the most important—and sometimes misunderstood—parts of DTAC.
It is not enough to demonstrate that your software works.
Manufacturers need to consider what could happen if the technology fails, produces incorrect information, presents information incorrectly, contributes to a workflow error or is used in circumstances that could expose patients to harm.
This is where clinical risk management and DCB0129 become particularly important.
NHS England identifies DCB0129 as the clinical risk management standard for manufacturers of health IT systems. Its counterpart, DCB0160, applies to health organisations deploying and using health IT systems. NHS England states that compliance with these standards is required under the Health and Social Care Act 2012.
For manufacturers working towards NHS DTAC readiness, understanding the distinction—and having the right clinical safety evidence—is essential.
If your digital health technology is heading towards the NHS, understanding the Digital Technology Assessment Criteria (DTAC) should be part of your market-access planning.
But one of the biggest mistakes manufacturers can make is treating DTAC as simply another questionnaire to complete.
The questions are only part of the process.
Behind your answers needs to be evidence showing that your technology and organisation have appropriate arrangements for clinical safety, data protection, technical security, interoperability, and usability and accessibility.
These five areas form the core of NHS DTAC. NHS England describes DTAC as national baseline criteria for digital health technologies entering NHS and social care.
For digital health manufacturers, the practical question is therefore not simply:
“Can we complete the DTAC assessment?”
It is:
“Can we demonstrate that our product meets the requirements?”
This guide looks at each of the five DTAC areas, the types of evidence manufacturers should consider and some of the common gaps that can delay NHS readiness.
A complete guide to NHS DTAC compliance for digital health manufacturers, covering the five DTAC assessment areas, required evidence, clinical safety, data protection, technical security, interoperability and usability, and how to prepare your digital health technology for NHS procurement.
Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
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