Helping you on your regulatory journey with expert Medical Device Regulatory Consultancy.
Patient Guard provide professional Regulatory Affairs and Quality Assurance services through Medical Device and In-Vitro Diagnostics consultancy.
Trusted by leading organisations across the UK, US & Europe
We provide a full range of industry-leading Medical Device Regulatory and Quality Services for a wide variety of medical device organisations across the UK, USA and Europe.
Internal auditing for medical devices plays a pivotal role in ensuring regulatory compliance, quality assurance, and patient safety within the healthcare industry.
We provide support in updating your technical including modifications or design updates to your device, revising and enhancing your risk management file, and ensuring your files are compliant.
Our clinical evaluation services are designed to support manufacturers in navigating the complex regulatory landscape, ensuring that their medical devices and IVDs meet the highest standards.
When it comes to launching your medical device in the US market, navigating the intricate landscape of FDA regulations is crucial.
Do you have a medical device or IVD idea? Are you a medical device start up? If so the prospect of medical device and IVD regulations can be daunting, especially if you have not done it before.
Once you have come up with the medical device or IVD concept, its time to start design and development.
Once the design has been finalised its time to transfer to manufacturing. This can be challenging and may require design changes to ensure that the device can be scaled.
Before you launch your medical device or IVD, it is important to ensure that you have met all of your regulatory obligations before placing product on the market.
Monitoring a medical device and IVD is important once it has been launched, to ensure that any unforeseen risks are captured and mitigated.
With over 20+ years of experience, we have not only amassed valuable insights but have also successfully guided lots of clients through the regulatory maze.
Recognising the unique nature of every Medical Device, our approach is highly customised. We meticulously tailor our services to meet the specific needs of your products and organisation, ensuring a personalised and effective regulatory strategy.
We offer comprehensive support that spans the entire product lifecycle. From initial consultations, to ongoing compliance management and even training courses, we are your dedicated partners.
We recognise the importance of time in the competitive landscape. Patient Guard prides itself on delivering timely and efficient services.
In choosing Patient Guard as your Medical Device Regulatory & Quality Assurance Partner, you’re not merely selecting a service provider; you’re opting for a dedicated partner committed to your success.
Patient Guard specializes in medical device and IVD (In-Vitro Diagnostic) regulatory consultancy. We provide expert support for CE Marking, UKCA marking, ISO 13485 Quality Management Systems (QMS) implementation, and FDA submissions to ensure your medical products meet global safety and performance standards.
We guide manufacturers through the entire technical documentation process. This includes creating and updating Technical Files, conducting Clinical Evaluations, and ensuring compliance with the latest EU MDR (2017/745) and IVDR (2017/746) regulations, as well as the UK Medical Device Regulations.
Yes. For non-UK manufacturers looking to sell in the United Kingdom, Patient Guard provides a designated UK Responsible Person service. We manage your MHRA registrations, maintain technical documentation, and act as your official liaison with UK regulatory authorities.
Our consultants provide end-to-end support for ISO 13485 implementation. This includes performing a gap analysis of your current systems, developing compliant QMS documentation, conducting internal audits, and providing full support during your Stage 1 and Stage 2 certification audits.
Absolutely. We help manufacturers establish robust Post-Market Surveillance plans and Vigilance reporting systems. Our team ensures that any adverse events are reported correctly to the relevant authorities and that your device’s safety and performance are monitored continuously after market launch.
Yes. We provide comprehensive Risk Management services in accordance with ISO 14971, ensuring that all potential hazards are identified and mitigated throughout the device lifecycle. Additionally, we author and update Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) to demonstrate the ongoing safety and clinical benefit of your products.
Patient Guard are an excellent source of medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with technical files all the way through to using their ISO templates to implement our ISO 13485 system.”
Richard Crow, Blue Tree Group
Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.”
Tracey Slater, Cormed
A milestone that strengthens our commitment to quality
Regulatory and quality consulting is one thing. Building, implementing, and passing audits on your own Quality Management System is another.
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Be the first to hear industry news and how Patient Guard can help you.
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
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
Thank you! The checklist is now ready to download.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
