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.
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.
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 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
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
If you’re entering the medical device market or managing regulatory compliance for the first time, one term you’ll hear frequently is UDI – Unique Device Identification. This system is critical to global regulatory frameworks and is rapidly becoming a non-negotiable requirement for manufacturers worldwide.
In this comprehensive beginner’s guide, we’ll
Welcome to our June 2025 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued.
The In Vitro Diagnostic Regulation (EU IVDR) 2017/746 has brought about a significant transformation in the regulatory framework for IVD devices across Europe. One of the most crucial components of this regulation is Article 10, which outlines the general obligations of manufacturers.
As IVD manufacturers work to meet new compliance
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Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
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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.
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