Regulatory Services for Medical Devices and IVDs in the United Kingdom

The UKCA (UK Conformity Assessed) marking is a new UK product marking that is required for certain products, including medical devices and in vitro diagnostic devices, placed on the market in the UK.  The UKCA marking replaces the CE marking in the UK following...

In the context of medical devices, compliance with the Medical Device Regulation (MDR) & In-Vitro diagnostic Regulation is necessary for obtaining CE Marking. The CE Marking service for medical devices involves the assessment and evaluation of the device's conformity with the requirements of the...

A UK Responsible Person (UKRP) is a legal entity appointed by a manufacturer, based outside of the UK, to fulfil the obligations of the UK Responsible Person as per the UK Medical Device Regulations (UK-MDR) and In-Vitro Diagnostic Regulations (UK-IVDR). The UKRP ensures that...

The MHRA Regulatory Consulting service provides expert guidance and support for medical device and IVD companies navigating the regulatory landscape in the UK. By leveraging the expertise of regulatory professionals, companies can streamline the process of gaining regulatory approval for their products and ensure...

QMS UK is a service that provides quality management system solutions for medical device and in vitro diagnostic manufacturers in the UK. The service helps clients implement and maintain compliance with the ISO 13485 standard, which is a requirement for obtaining and maintaining regulatory...