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UK & EU Medical Device Consultancy Services

Expert regulatory affairs and quality assurance consultancy supporting manufacturers through the entire device lifecycle—from classification and clinical evaluation to market access.

Medical Device Consultancy Services

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.

David Small - Patient Guard - CEO and Founder

"In a regulatory landscape as volatile as the 2020s, compliance shouldn't be a hurdle—it should be your competitive advantage. My time at the MHRA taught me that the best clinical innovations only succeed when they are backed by a defensible, regulator-ready strategy. We exist to be that shield for your business."

David Small BSc (Hons), MSc, MTOPRA

Founder and CEO

Why Choose Patient Guard for Medical Device Consultancy?

Expert Regulatory Insight

Our team consists of highly experienced regulatory affairs and quality assurance professionals dedicated to simplifying compliance frameworks.

Pragmatic & Lean Systems

We don't believe in unnecessary administrative bloat. We build practical, efficient systems designed to fit your unique business operations.

Global Market Access

From UKCA and CE Marking to FDA submissions, we provide comprehensive strategic pathways to launch your devices in global markets.

Trusted Industry Partner

Since 2017, hundreds of global medical device and IVD manufacturers have trusted us to secure and maintain their compliance status.

End-to-End Project Delivery

We work as an extension of your team, actively authoring documentation and supporting you all the way through to successful audit completion.

Proportionate Risk Strategies

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.

What Our Medical Device Consultancy Service Includes

Regulatory Strategy & Access

Developing robust, defined routes to market for UKCA (MHRA), CE Marking (MDR/IVDR), and international global registrations.

Quality Management Systems

Designing, implementing, and maintaining fully compliant QMS frameworks tailored precisely to EN ISO 13485, ISO 9001, and ISO 27001 standards.

Technical File Compilation

Authoring and updating technical documentation to ensure absolute alignment with rigorous Notified Body and regulatory expectations.

Clinical & Performance Evaluations

Compiling comprehensive Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) utilizing solid evidence streams.

Risk Management & Compliance

Establishing comprehensive risk files under EN ISO 14971, linking product hazards seamlessly with your active safety and design data.

Post-Market Surveillance

Setting up proactive PMS loops, PMCF/PMPF plans, and trend tracking architectures to successfully maintain long-term compliance lifecycle safety.

Stage	What Patient Gauard 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.

Who Requires Medical Device Consultancy?

Medical device manufacturers
Start-ups developing new devices
Companies entering EU, UK, or US markets
Organisations preparing for audits or inspections
Businesses requiring regulatory remediation support

Regulatory Frameworks We Support

We provide consultancy across key global regulatory frameworks, including:

Our Process

Initial consultation

We assess your product, regulatory requirements, and current status.

Gap analysis

We identify compliance gaps and define a clear action plan.

Implementation support

We support documentation, systems, and regulatory activities.

Review and validation

We ensure your systems and documentation meet regulatory requirements.

Ongoing compliance

We provide continued support for audits, inspections, and updates.

Areas we support

We provide consultancy across all key regulatory and quality areas, including:

CE marking and UKCA marking
Technical File and Design Dossier preparation
Clinical Evaluation Reports (CER)
Risk management documentation
Quality system implementation and auditing
Regulatory submissions and strategy

Cost of Service

Premium

Medical Device Consultancy

£ 150

£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.

Features

Flexible, On-Demand Support
Experienced Regulatory Specialists
Practical, Actionable Advice
Scalable to Your Project Needs

Get Started

Time Lines

Day 1 – Initial Consultation & Scope Definition

We discuss your requirements, challenges, and define the scope of support needed.

Day 1–3 – Immediate Advisory & Action Plan

We begin providing guidance, identify key gaps, and outline clear next steps.

Ongoing – Flexible Support & Delivery

Continued consultancy support tailored to your project timeline, priorities, and regulatory needs.

Frequently Asked Questions (FAQs)

What does a medical device consultant do?

A medical device consultant supports manufacturers with regulatory compliance, quality systems, and documentation required to bring and maintain products on the market.

When should I engage a consultancy?

Ideally at the early stages of product development, but consultancy support can be provided at any stage of the lifecycle.

Can Patient Guard support start-ups?

Yes, we regularly support start-ups with regulatory strategy, CE marking, and QMS implementation.

Do you support global regulatory compliance?

Yes, we support EU, UK, and US regulatory frameworks.

How quickly can support begin?

Support can typically begin within a few days depending on project scope.

Related Services

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Do you need Training?

Check out Patient Guards Training Courses

Recent Blog Posts

EU Authorised Representative Services for Medical Device & IVD Manufacturers

June 27, 2026 No Comments

Selling medical devices or IVDs in Europe? If your company is based outside the EU, appointing an EU Authorised Representative (EC Rep) is a legal requirement under EU MDR 2017/745 and IVDR 2017/746. Patient Guard provides expert EU Authorised Representative services, EUDAMED support, regulatory guidance, and ongoing compliance management to help manufacturers access and maintain the European market with confidence.

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