FOR PEOPLE WHO CARE
BY PEOPLE WHO CARE
FOR PEOPLE WHO CARE
BY PEOPLE WHO CARE
We bring medical devices to the UK and EU markets and provide Legal Manufacturer and regulatory support services to companies seeking market access.
Technical documentation, conformity assessment, notified body engagement, and regulatory submissions for UK and EU market access.
Comprehensive quality management systems including document control, CAPA, supplier management, and internal audit programmes.
We assume the role of Legal Manufacturer for third-party devices, taking on full regulatory responsibility for UK and EU market placement.
Complaint handling, vigilance reporting, trend analysis, and periodic safety update reports to fulfil ongoing regulatory obligations.