PCML Group – awarded ISO13485 certification for the production of medical grade devices and components.

PCML Group, have recently been awarded ISO13485 certification for the design, manufacture and assembly of Class I and Class II medical grade devices and components – for MedTech and Biotech companies in the UK’s medical industry.

From our innovation centre in Cambridge – one of the UK’s leading innovation hubs for medical research and product development – we manufacture, assemble, quality check and test a range of medical equipment – from surgical robotics and medical devices to 3D imaging, diagnostic testing equipment and scientific instruments.

Carl Dean, Engineering Director – PCML Group.
“We have been operating in accordance with IS013485 for some time.

Certification reassures clients that investments in our procedures, cleanroom facilities and specialist engineers guarantee the regulated and quality-controlled environment necessary for the manufacture and complex assemblies of medical grade devices and components”.

Neal Lawrence, UK Sales Manager – PCML Group.
“PCML’s response to the rising global demand for medical grade components and products is being driven by continued technological advancements in the medical industry – and a shift towards smart manufacturing and efficient supply chain management.

Customers are looking for dynamic and flexible supply chains with rapid turnaround and customised specifications.

PCML is well positioned to deliver this – leveraging our technology, IT infrastructure and automated processes to provide the manufacturing agility that our clients require, along with rapid turnaround, design and technical design input and market leading engineering capabilities”.

 

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