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.
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 up for manufacturing.
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 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
For a free consultation about your Medical Device Regulatory & Quality Assurance needs.
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
Great news everyone! Patient Guard is thrilled to bring you fresh updates
through our May 2024 newsletter. We’re super excited to share that
we’ve started offering Training courses – kicking off with our inaugural course on ‘EU Medical Device Regulations 2017/745’.
As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy.
We have been busy updating our
In medical device design, the efficacy, safety, and user experience is paramount. While the technical function of a device is unquestionably significant, its usability can often determine its real-world impact. This is where standards like IEC 62366-1 come into play, offering a structured approach to integrating user-centred design principles into
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Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
