Medical Device Regulatory Consulting

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

Our core services

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.

Auditing
Services
Internal auditing for medical devices plays a pivotal role in ensuring regulatory compliance, quality assurance, and patient safety within the healthcare industry.
Biological
Evaluation
Medical device biological evaluation is a critical aspect of ensuring their safety and efficacy for use in healthcare settings.
Cosmetic
Responsible Person
Cosmetics regulations are comprehensive frameworks designed to ensure the safety, quality, and efficacy of cosmetic products while safeguarding consumer health.
Medical Device
Consultancy
We are dedicated to helping manufacturers navigate the complexities of regulatory compliance and achieve market success.
CE Mark & UKCA Mark
Technical Files
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.
Clinical
Evaluation
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.
Quality Management
System
Medical device quality management is a comprehensive framework designed to ensure that medical devices consistently meet the regulatory requirements as well as fulfil the needs and expectations of patients and healthcare providers.
FDA
Services
When it comes to launching your medical device in the US market, navigating the intricate landscape of FDA regulations is crucial.

Our Approach

We can help you at any stage of the Medical Device and IVD Regulatory roadmap

Concept

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.

Design

Once you have come up with the medical device or IVD concept, its time to start design and development.

Manufacturing

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.

Launch

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.

Post Market

Monitoring a medical device and IVD is important once it has been launched, to ensure that any unforeseen risks are captured and mitigated.

Obsolescence

Need to understand your obligations?

Helping you on your Regulatory Journey.

Find out how Patient Guard can help you bring your product from concept to obsolescence.

Why Organisations Choose Patient Guard

Expertise &
Experience

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.

Tailored
Solutions

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.

End-to-End
Support

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.

Timely
& Efficient

We recognise the importance of time in the competitive landscape. Patient Guard prides itself on delivering timely and efficient services.

Committed
Partners

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

Our Friendly Team are here to help.

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

Latest news from Patient Guard

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May 2024 News letter from patient guard for all the latest medical device and IVD regulatory and quality assurance news.

May 2024 News Letter

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’. We’re planning to conduct these insightful sessions once every

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Hello April, spring related motivational quote, isolated on white background, vector illustration. Handwritten letters, Japanese sakura branch, little cute flowers falling. Used by Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy agency for their April news letter.

April 2024 – News Letter

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

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Do you need support with Medical Device or IVD compliance?

We can help you!