Quality standard approves medical device design

Plexus UK has achieved ISO13485 approval for medical device design for its design centre in Livingston and its rapid-prototyping and volume manufacturing site in Kelso.

Plexus UK has achieved the demanding ISO13485 quality approval for medical device design.

Plexus is now certified to this standard for its design centre in Livingston and its rapid-prototyping and volume manufacturing site in Kelso, Scotland.

The ISO13485 standard takes a process approach to quality management.

According to Andy Allen, Plexus VP Europe: "The medical device market is fundamental to our business in Europe".

"The design, development and manufacture of devices for this market require an extremely high process standard".

"The award of ISO13485 demonstrates our commitment to the regulatory requirements related to the design of medical devices".

He adds: "Accreditation of all our process from design through to product shipment means that our customers can be assured of first rate practices, enabling them to manage and plan their product introductions without concern".

ISO13485 is the quality management standard based on ISO9000 and as such documents in full the design processes and structure of the registered company.

This means that companies subcontracting to a registered design and manufacturing house do not have to perform that part of the approvals process themselves, enabling them to shorten their route to Medical Device Directive CE marking.

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