Q.1492 Consultancy to Obtain CE Marking and ISO13485

Descriptions

NHS Wales Shared Services Partnership, Procurement Services, on behalf of Betsi Cadwaladr University Health Board, are seeking to appoint a suitably qualified Contractor to provide consultancy, advice and assistance to the Health Board’s Posture & Mobility Service in order to meet the following objectives:1. To obtain CE marking approval from a Notified Body for medical devices.2. To set up a Management System for Medical Devices to the ISO 13485 standard.It is expected that a consultant/agency working with the Service would be able to advise on and help facilitate delivery of the following elements to achieve the above goals:Setting up systems for CE Marking of Medical DevicesSetting up systems for meeting customer requirementsSetting up common ISO systemsFacilitate or provide Auditor TrainingIdentify appropriate Accreditation BodiesMonitor External Assessment – attendance and supportMonitor Management Review – attendance and supportThe contract duration is anticipated to be no longer than 12 months as this is a priority for the Posture & Mobility Service.For further information please refer to the Specification attached to the ITT which can be found by accessing www.etenderwales.bravosolution.co.ukNOTE: The authority is using eTenderwales to carry out this procurement process. To obtain further information record your interest on Sell2Wales at http://www.sell2wales.gov.uk/search/search_switch.aspx?ID=29813