Quality & Regulatory

Quality

It is the policy of CME Medical to provide infusion pumps, consumables, accessories and the associated servicing and training that continually meet or exceed our customers’ needs and expectations with respect to quality, safety and reliability.

Our aims are:

  • to ensure compliance with relevant statutory requirements
  • to resolve complaints in an effective and timely manner thus ensuring continued customer satisfaction
  • to endeavour at all times to maximise customer satisfaction by continual improvement of the system
  • to achieve and maintain a level of quality which ensures maximum patient safety whilst enhancing the company’s reputation
  • to achieve timely delivery of products and services to meet our customer’s requirements.

Quality assurance / regulatory

CME Medical’s Quality Assurance system complies with and is certified to ISO 9001: 2008 and with the addition of ISO 13485:2003 for our Technical Services (service and repair activity).

Our quality assurance department ensures that the company is compliant with any new or changing statutory requirements.

Compliance with Medical Device Directive 93/42/EEC.

All medical devices distributed by CME Medical are CE marked demonstrating conformity to the European directive 93/42/EEC.

We are registered for the responsible disposal of electronic equipment and batteries – WEE/CB2230WW.

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If you have any questions or feedback relating to quality assurance or product quality, please complete this form.

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