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.
PRRC Service
Following the introduction of the Medical Device Regulation, MDR (EU) 2017/745, and In Vitro Diagnostic Regulation, IVDR (EU) 2017/746, comes…
Biological Evaluation ISO 10993
Do you have a medical device that will come into direct or indirect contact with the patient or user? It…
Medical Device Registration
All Medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered in the relevant countries or…
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…
EU Responsible Person Service
European Cosmetics Responsible Person In European Union (EU) countries and the wider economic area (Turkey, Switzerland, Liechtenstein, and Norway) Cosmetic…
Clinical Evaluation
Clinical Evaluation Clinical Evaluation is an integral part of making sure Medical Devices perform as intended within their clinical use…
EU Medical Device Registration
The European Union (EU) requires medical device manufacturers based outside of the EU to appoint an EU Authorized Representative who…
UK Medical Device Registration
The United Kingdom (UK) requires medical device manufacturers based outside of the UK to appoint a UK Responsible Person who…
