Quality Approved

ST+D operates a Quality Management System which is audited and accredited by :

SGS UK Ltd, Yarsley International Certification Services

ISO 13485:2003 Medical Devices

ISO 9001:2000 Quality Management System

ISO 13485:2003 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 producing CE marked devices to both MDD and FDA requirements.