In the medical device industry where cleanliness, quality and compliance are important, Contour’s experience of medical cable assemblies and clean room manufacturing is playing a vital role.
A highly qualified, expert partner
We support our customers by transforming concepts and specifications through design engineering, prototyping, pre-production and final box build into a medical device suitable for volume production.
We can assist with the selection of ISO10993 compliant, bio-compatible materials which can withstand sterilization processes such as irradiation, EtO or autoclaving. Using the Far East as our manufacturing base, we provide low cost cable assembly and injection moulding in our purpose built Class 7 clean room.
We also provide assistance with design verification and validation activities and undertake testing with new and unproven designs.
Effective implementation of IQ, OQ and PQ ensures full validation of internal processes and we provide full documentation of our processes to enable regulatory compliance with medical device directives.
We have been incorporating SteriTouch® masterbatch into our cable assemblies for several years. The SteriTouch® products that we use are based on ionic silver. The difficulty with which organisms are able to develop resistance to ionic silver makes it a useful tool in areas where resistance to organic biocides may be a problem. The SteriTouch® masterbatch added at the extrusion process has no adverse effect on the performance of the base material and will remain effective for the life of the product.