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, BSc (Hons), MSc, MTOPRA - Founder and CEO
David is a distinguished regulatory strategist with over 20 years of experience across the life sciences sector. Most notably, he served as a Higher Medical Device Specialist at the MHRA, providing him with “inside-the-regulator” perspective that is invaluable to our clients.
His career spans the clinical and commercial spectrum, including roles within the NHS as a Biomedical Scientist and senior Quality & Regulatory positions in industry. David holds a BSc (Hons) in Biomedical Science and an MSc in Analytical Bioscience and Drug Design. He is a recognized member of the British Toxicological Society (BTS) and The Organisation of Professionals in Regulatory Affairs (TOPRA). Under his leadership, Patient Guard has become a premier consultancy for UK and EU market access.
Steve Condie, MTOPRA - Regulatory Manager
Steve brings over 20 years of specialized experience to the life sciences sector, with a profound expertise in Toxicology testing and ISO 10993 Biocompatibility evaluation. As a critical link in the regulatory process, Steve helps manufacturers navigate the complex requirements of biological safety, ensuring robust and compliant technical documentation for global market submissions.
A BSI-trained ISO 13485 Internal Auditor and a registered member of The Organisation of Professionals in Regulatory Affairs (TOPRA), Steve combines technical scientific knowledge with a deep understanding of Quality Management Systems (QMS). His dual expertise in lab-based safety standards and regulatory strategy makes him an essential asset for clients managing high-risk device classifications.
Alex Lewis, BSc - Lead Auditor and Quality Manager
Alex combines high-level technical expertise with a deep-rooted commitment to patient-centric innovation. Holding a BSc in Biomedical Science, he possesses a fundamental understanding of the life sciences that informs his 15+ years of experience in Quality Assurance.
Alex is a BSI-qualified Lead Auditor for ISO 27001 (Information Security) and is BSI-trained for ISO 13485 (Medical Devices). He specializes in the implementation and auditing of integrated Quality Management Systems (QMS) that bridge the critical gap between medical device safety and data security—an essential requirement for the modern Software as a Medical Device (SaMD) and connected health markets.
Alex serves as the Quality Manager at Patient Guard, where he successfully designed and implemented our ISO 13485:2016 Quality Management System, recently achieving certification through BSI. This hands-on experience in navigating a BSI audit from the inside provides Alex with a unique “practitioner’s perspective” when supporting our clients.
Eleanor Shackleton, BSc - Clinical & Regulatory Specialist
Eleanor is a highly qualified Clinical and Regulatory Specialist with a focus on the rigorous documentation required for global market access. With a foundational background in the life sciences, she has built an extensive portfolio of specialist certifications from leading notified bodies and training institutions, including BSI and PharmaSchool.
Eleanor specializes in bridging the gap between clinical data and regulatory compliance. She is an expert in Clinical Evaluation under the EU MDR 2017/745 and Performance Evaluation under the IVDR 2017/746. Her technical expertise extends to specialized areas such as Medical Devices with Ancillary Medicinal Substances and the critical General Safety and Performance Requirements (GSPR).
A strong advocate for patient safety through robust data, Eleanor holds a 2022 ICH GCP (Good Clinical Practice) Certificate with a high distinction score of 92%. She is also highly proficient in Risk Management for Medical Devices (ISO 14971:2019) and global labelling standards including ISO 15223. At Patient Guard, Eleanor ensures that our clients’ technical files are not just compliant, but defensible against the highest levels of auditor scrutiny.
Eleanor also supports global market access through her training in US FDA Medical Device Regulatory Affairs.
Jackie Brooks – Operations Manager
Jackie is the operational lead at Patient Guard, ensuring the seamless delivery of complex regulatory projects for our global client base. Bringing over 20 years of experience from Healthpoint Ltd, a leader in healthcare and consumer products, Jackie has a deep-seated understanding of the supply chain, procurement, and commercial pressures faced by manufacturers.
With an extensive background as a Senior Buyer, Jackie specializes in high-standard service delivery and operational excellence. Her unique insight into the lifecycle of healthcare products—from raw material sourcing to retail-ready consumer goods—allows her to optimize our internal processes and ensure that every client engagement meets our rigorous standards for quality and efficiency.
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
EUDAMED Authorised Representative SRN: DE-AR-000007523
EUDAMED Importer SRN: DE-IM-000025621
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.
We were really pleased with the solid and responsive support we received throughout our medical device registration process.
From the outset, Patient Guard were clear about why organisations choose them, and they truly delivered on that promise.
They brought together a wide range of expertise across every aspect of the process, tailored their support to our specific type of medical device, and provided timely, reliable guidance at every stage.
They delivered everything within the agreed timeframe and were always available to answer our questions. We would definitely recommend Patient Guard to others.
Julie Evason, Health Diagnostics Ltd
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.
What makes Patient Guard different from other regulatory consultancies?
Patient Guard combines deep regulatory expertise with a practical, hands-on approach. We don’t just advise—we work alongside you to implement compliant, efficient solutions that align with your business goals.
Can you support companies outside the UK and EU?
Yes. While we specialise in UKCA and CE marking requirements, we regularly work with international clients looking to access or maintain compliance in the UK and EU markets.
News from Patient Guard
The MHRA 2026 Regulatory Roadmap Explained
Learn how the MHRA 2026 Regulations will impact UKCA compliance, IVD classifications, AI medical devices, IRP pathways, and post-market surveillance.
Medical Device Regulatory Consulting Services Explained
Explore medical device regulatory consulting services for ISO, FDA, EU, and more. Build compliant systems, pass audits, and scale globally
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
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.
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I really appreciate the monthly news letter which summarises any changes/ news to regulations and standards.
This is very helpful to me and in addition, is considered a great service by our ISO13485 external auditor. They were very impressed when I showed them your monthly news letter at our latest audit.
We can clearly demonstrate that we are on top with the regulative requirements, as I read and check your news letter.”
Viktoria Kowal, Gallant
