Integra | Cranial Pressure Monitor

Product Upgrade & Electronics Manufacturing

This medical hand-held product, for the monitoring of cranial pressure, incorporated an LCD display that was withdrawn by the supplier at short notice, threatening the life expectancy of the client’s product.


4e were tasked with upgrading the unit for use with an alternative display, while minimising FDA re-qualification of the product,  and then to provide ongoing electronic manufacture and assembly of the product including End of Life Management to guard against obsolescence issues.


4e maintained strict medical documentation in line with our ISO 13485 quality manufacture accreditation.  We supervised management of the units’ supply chain, enabling a seamless transition for our client to the new LCD display.  The unit consisted of surface-mount PCAB assemblies, touch screen display, pressure probe transducer, cable assemblies and plastic enclosures.


Key Services Supplied to this Case Study:

•  Experienced Technical Knowledge and Design Support
•  ISO 13485 Manufacturing
•  Supply Chain Management
•  Life Time Product Management
•  Component Obsolescence Management


From design conception, through to product end of life management. 4e can help support your product.


Contact the team at 4e