Plexus UK has achieved ISO13485 quality approval for medical device design. The certification applies to its design centre in Livingston and its rapid-prototyping and volume manufacturing site in Kelso, Scotland. Plexus VP Europe, Andy Allen, said: The medical device market is fundamental to our European business. The design, development and manufacture of devices for this market require an extremely high process standard, so ISO13485 demonstrates our commitment to the medical regulatory requirements. Accreditation of all our process from design to product shipment means customers can be assured of first rate practice, enabling them to plan their product introductions without concern.
The ISO13485 quality management standard means companies subcontracting to a registered design and manufacturing house do not have to perform that part of the approvals process themselves. This can help to shorten their route to medical device directive and CE marking.