Quality Assurance

International Medical Devices Plc regards itself as a high-quality medical device developer, manufacturer and distributor. The group operates with technical and administrative controls to assure safety and reliability both under European regulations and to customer requirements.

ISO 9001:2003 is the standard for general quality assurance.

All subsidiaries in the IMD group operate to this standard.

ISO 13485:2003 is the standard specific to medical devices and requires higher levels of detail to quality in all areas of development, production and distribution, and also requires stringent detail and retention of technical data, complaints and follow-up, environment monitoring, risk identification and analysis, and accountability/traceability. ISO 13485:2003 is globally recognized as the most stringent standard of quality control for medical devices.

Two subsidiaries of IMD have ISO 9001:2000 13485:2003 certification.


Response Medical Equipment Ltd
 
 
 

EMS Medical Ltd
 
 

IMD is committed to delivering the highest quality products possible to our customers and it is particular gratifying to receive third party endorsement of our Quality management process. ISO 13485:2003 is another step in the implementation of the Company's strategic plan to acquire and exploit IP and distribution rights in the major world markets. The directors of IMD consider this ISO 13485:2003 certification an important distinguishing factor and a major competitive advantage for the Company.
 

Medical Device Directive 93/42/EEC Annex V is a directive specifically concerned with Production Quality Assurance.
 

Response Medical Equipment Ltd conforms to this directive.