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 A clinical evaluation is an integral part of the registration of medical devices. The clinical evaluation report ensures…

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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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