Medical equipments

Tender description

The scope is sizes 3F — 12F of a subcutaneous securement device for use with percutaneous catheters. It must attach to the catheter shaft so it can be lifted off the skin to allow cleaning of the insertion site. This would exclude any other types of securement devices, catheters and any other related products. The scope is sizes 3F — 12F of a subcutaneous securement device for use with percutaneous catheters. It must attach to the catheter shaft so it can be lifted off the skin to allow cleaning of the insertion site. This would exclude any other types of securement devices, catheters and any other related products. The following certification will be a requirement of the upcoming procurement. There will be no option to commit to obtain any of the certificates and declarations of conformity detailed below. ISO 13485:2016 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage and distribution. The requirement is that ISO 13485:2016 or equivalent externally accredited and up-to-date quality standard certificate(s) is in place prior to the commencement of the framework agreement (in order for NHS supply chain to trade with the successful applicant). Compliance to the Medical Devices Directive 93/42/EEC. Applicants will be required to evidence: 1) A valid, in date CE certificate issued by a notified body covering the scope of products that are to be tendered for; and 2) An EC declaration of conformity covering all tendered product lines (please note multiple certificates and declarations are acceptable).