About Patient Guard
Regulatory experts supporting medical device, IVD, cosmetic and PPE companies across the UK and EU
Patient Guard
Trusted by over 500 clients since 2017, Patient Guard is a regulatory and Quality Assurance consultancy supporting manufacturers, distributors and innovators across the medical device, IVD, cosmetic and PPE sectors. We help organisations achieve and maintain compliance in the UK and EU through practical regulatory guidance, quality management support and authorised representative services.
Who We Are as a Regulatory & Quality Assurance Consultancy
Patient Guard works with companies at every stage of the product lifecycle, from early development through to market access and ongoing compliance. Our team supports businesses with clear, reliable and commercially practical advice so they can navigate complex regulatory requirements with confidence.
We work across medical devices, in vitro diagnostics, cosmetics and PPE, helping our clients meet regulatory expectations while protecting quality, safety and performance. With registered operations in both the United Kingdom and Germany, we are well placed to support organisations trading across the UK and EU markets.
Our Mission
Our mission is to support medical device and IVD manufacturers in bringing safe, compliant and effective products to market. We provide expert regulatory guidance, quality management support and authorised representative services that help organisations navigate complex regulatory frameworks with confidence. Through our work, we contribute to improved patient safety and better healthcare outcomes worldwide.
Tracey Slater, Cormed
Some of Our Clients
Why Companies Choose Patient Guard
Meet the Team
Medical Device, IVD, Cosmetic and PPE Regulatory Expertise
We provide a full range of regulatory and quality assurance services to support manufacturers, developers and distributors across medical devices, IVDs, cosmetics and PPE. Our services are designed to help organisations meet regulatory requirements efficiently while building strong foundations for long-term success in the UK and EU markets.
Our Experience and Credibility
Since 2017, Patient Guard has supported more than 500 customers with regulatory and quality compliance. Our team brings qualified, experienced and accredited expertise across medical devices, IVDs, cosmetics and PPE.
We operate through registered entities in both the UK and Germany, giving clients access to support across key European markets. Patient Guard also operates a BSI-certified ISO 13485 quality management system, demonstrating our commitment to quality and compliance.
David Small - Founder/CEO
An experienced regulatory strategist with more than 20 years in the life sciences industry, including previous experience at the MHRA. He has led the growth of Patient Guard into a trusted consultancy supporting compliance across the UK and EU.
Steve Condie - Regulatory Manager
With more than 20 years of experience in the life sciences sector, expertise in toxicology testing and ISO 10993 biocompatibility evaluation. He supports clients in developing strong and compliant technical documentation.
Alex Lewis - Quality Assurance Manager
Alex has over 15 years of experience in quality assurance and is a lead auditor. He specialises in implementing quality management systems aligned with ISO 13485, ISO 9001 and ISO/IEC 27001.
Eleanor Shackleton - Clinical & Regulatory Specialist
With more than 10 years of experience, she specialises in clinical evaluation for medical devices and performance evaluation for IVDs, supporting robust and compliant documentation.
Jackie Brooks – Operations Manager
Bringing operational experience from across healthcare products, medical devices and consumer goods, she ensures smooth operations and high standards of service delivery.
Our Locations
Patient Guard Ltd
Lancaster House Amy Johnson Way, Blackpool, Lancashire, FY2 4RP. United Kingdom
Company Registration Number: 10654752
Patient Guard Europe UG (haftungsbeschränkt)
Hauffstraße 41, 73765, Neuhausen, Deutschland (Germany)
Company Registration Number: HRB 779309
Our Partners
We work with a trusted network of partners to provide additional specialist support where required. This includes testing and validation, clinical investigation support, financial and funding services, and notified body or approved body services.
Need Support with Compliance?
Whether you need regulatory guidance, quality management support or authorised representative services, our team is here to help. Speak to Patient Guard about your compliance needs in the UK and EU.
Frequently Asked Questions (FAQs)
What does a medical device regulatory consultancy do?
A medical device regulatory consultancy supports companies in achieving and maintaining compliance with regulations such as EU MDR and UKCA. This includes preparing technical documentation, implementing ISO 13485 quality management systems, conducting clinical evaluations, and providing authorised representative services.
By working with a consultancy, manufacturers can accelerate time to market, reduce compliance risks, and ensure their products meet all regulatory requirements in the UK and EU.
Do you support EU CE marking and UK UKCA marking compliance?
Yes, we provide full support for CE and UKCA compliance. Our team helps manufacturers navigate regulatory requirements, prepare documentation, implement quality systems, and achieve successful market access in both the EU and UK.
Whether you are launching a new product or maintaining compliance for existing devices, we provide practical, end-to-end regulatory support.
Can you act as an authorised representative?
Yes, we provide EU Authorised Representative and UK Responsible Person services. This allows manufacturers outside the EU and UK to place their products on the market while meeting all regulatory requirements.
Our team manages regulatory responsibilities, supports communication with authorities, and helps ensure continued compliance throughout the product lifecycle.
Do you support Quality Management Systems implementation?
Yes, Patient Guard supports ISO 13485, ISO 9001 and IEC/ISO 27001 implementation for manufacturers. We help organisations establish, implement and maintain compliant quality management systems aligned with the standards requirements.
Our support includes gap analysis, documentation development, process design, internal audits, and preparation for certification audits. We work closely with your team to ensure your quality management system is both compliant and practical for your business.
News from Patient Guard
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,
Clinical Evaluation Report: EU MDR Requirements
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Medical Device Labelling Requirements Explained
Medical device labelling is more than a packaging exercise. It is a regulatory requirement that communicates essential information about a
Medical Device Post-Market Surveillance Guide
Regulatory approval is not the end of scrutiny, it is the beginning of structured data collection.
