US OK for Scottish medical manufacture
The Aixplorer is a complete ultrasound system with FDA approval and CE Mark since 2009
Electronic manufacturing services company, Plexus Corporation, has received approval from the US Food and Drug Administration (FDA) to manufacture finished class II medical devices at its Kelso site.
Plexus achieved the accreditation following a thorough assessment of its work with SuperSonic Imagine, a French medical OEM, on the design and manufacture its Aixplorer ultrasound system.
Plexus has worked closely with SuperSonic Imagine through the product realization process, providing support with prototyping, live scan testing, electronic and high level systems assembly as well as providing direct order fulfilment.
Plexus, which also holds ISO13845 accreditation in recognition of the quality management systems in place at its Kelso manufacturing facility, has the capabilities to configure Aixplorer to the specific requirements of SuperSonic Imagine customers prior to shipping.
“Plexus has a proven track record in creating high complexity medical electronic devices,” comments Chris Griffin, senior director of customer Management EMEA. “As well as our high standards of accreditation, we understand the needs of our medical customers and can offer the flexibility, expertise and support to design and manufacture the next generation of industry leading medical devices. We are very proud to be engaged with SuperSonic Imagine on this programme.”
“It is extremely important to us to work with an integrated partner who can support us in producing our highly innovative ultrasound systems,” adds Pascal Roncalez, hardware director, SuperSonic Imagine. “SuperSonic Imagine is now marketing Aixplorer to the United States directly from Plexus’ Kelso facility, offering our customers the option of customised configuration to meet their specific requirements.”
The Aixplorer is a complete ultrasound system with FDA approval and CE Mark since 2009, and is used for breast, liver, abdomen, thyroid, musculoskeletal, prostate, gynaecology, 3D breast and vascular scanning.
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