Medical Device

Patient Guard’s Regulatory Affairs (RA) consultants can aid your company with requirements for compliance with regulatory technical documentation. If your medical device requires; Technical File Creation, Biological Evaluation, Clinical Evaluation, registering to a specific medical market via our registration services or on-going regulatory compliance assistance– Please see the list of services we provide and contact us for more information.

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PRRC Service

Following the introduction of the Medical Device Regulation, MDR (EU) 2017/745, and In Vitro Diagnostic Regulation, IVDR (EU) 2017/746, comes…

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Biological Evaluation ISO 10993

Do you have a medical device that will come into direct or indirect contact with the patient or user? It…

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Medical Device Registration

All Medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered in the relevant countries or…

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Medical Device File (Technical File) Creation

A Medical device technical file is a compilation of the documentation required to demonstrate compliance to the relevant regulation. The…

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EU Responsible Person Service

European Cosmetics Responsible Person In European Union (EU) countries and the wider economic area (Turkey, Switzerland, Liechtenstein, and Norway) Cosmetic…

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Clinical Evaluation

Clinical Evaluation Clinical Evaluation is an integral part of making sure Medical Devices perform as intended within their clinical use…

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EU Medical Device Registration

The European Union (EU) requires medical device manufacturers based outside of the EU to appoint an EU Authorized Representative who…

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UK Medical Device Registration

The United Kingdom (UK) requires medical device manufacturers based outside of the UK to appoint a UK Responsible Person who…

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