Intelesens operates a Quality Management System which is audited and accredited by:
SGS United Kingdom Limited
ISO 13485 Medical Devices
ISO 13485 standard is recognised as the basis for quality systems meeting the Council of the European Communities Medical Device Directive 93/42/EEC.
The Company is registered with MHRA (Medicines and Healthcare products Regulatory Agency) the UK Competent Authority for placing medical devices on the market within the EU member states as required by the Medical Devices Regulations 2002: Regulation 19. As an OEM the Company has experience in manufacturing medical devices that meet both CE and FDA requirements.