Patient Guard
Our Services
What We Do
Patient Guard provides all the knowledge and regulatory experience you will need to meet the hurdles associated when putting medical devices on the market and maintaining their compliance, whether you have an existing product, an enhanced model, or a completely new invention. You can make use of our knowledge to streamline the procedure and ease the burden of regulation on your company. Patient Guard has always supported medical equipment manufacturers across a variety of sectors. You can get assistance from our staff with any aspect of regulatory affairs and quality assurance. We all have experience working in the industry, so we understand how different from your regular job a regulatory project may be and the potential harm that time away from your regular operations can have on your firm.
Patient Guard works on regulatory matters in numerous jurisdictions daily; therefore, we are able to help at all levels and during the whole life of your medical device:
01.
Medical Device Consultancy
Patient Guard provides all the knowledge and regulatory experience you will need to meet the hurdles associated when putting medical devices on the market and maintaining their compliance, whether you have an existing product, an enhanced model, or a completely new invention…
02.
PRRC Services
The new requirement that manufacturers have at least one Person Responsible for Regulatory Compliance (PRRC) on hand within their organisation is outlined in Article 15 of both the Medical Device Regulation 2017/745 (MDR) and In-vitro Diagnostic Regulation 2017/746 (IVDR)…
03.
CE Mark & UKCA Mark Technical Files
As of 1st January 2021 the United Kingdom (UK) became a third country and broke away from the European Union (EU), Medical Devices & IVD (In Vitro Diagnostic) Devices sold in the UK are now required to be compliant to the UK Medical Device Regulations 2002…
04.
UK Responsible Person
Manufacturers from outside of the UK must designate a UK Responsible Person (UKRP), as defined in the UK Medical Devices Regulations 2002, with a registered place of business in the UK in order to market a medical device or IVD in Great Britain (SI 2002 No 618, as amended)…
05.
EU Authorised Representative
The European Union (EU) requires medical device manufacturers based outside of the EU to appoint an EU Authorized Representative who has a registered premises in an EU member country to act on behalf of the medical device manufacturer, for the purposes of registering…
06.
Biological Evaluation
All medical devices which have direct or indirect contact with the user/patient must be evaluated for their biocompatibility. This is a key area of medical device validation to identify that it is unlikely to cause any biological adverse effects in humans…
07.
Clinical Evaluation
Clinical Evaluation is an integral part of making sure Medical Devices perform as intended within their clinical use and are as safe as practically possible before and after they are placed on the market…
