Selecting Computer Systems Integrators for Medical Device Manufacturing Success
The makers of medical devices, ranging from ultrasound machines to diagnostic laboratory equipment, are experts in their technological specialties. But not surprisingly, many those manufacturers are not, and do not wish to become, experts in PC selection, qualification, support, and integration.
Instead, many medical device manufacturers (MDMs) seek out reliable partners who can provide, configure, certify, and ensure continuing availability of computing systems, so they can focus their own resources on optimizing the capabilities of their tests and modalities. These companies act as the MDM’s system integration partner in obtaining, customizing, and documenting computing systems. They give device manufactures the cachet of a leading computer manufacturer’s nameplate on the system, combined with the upgrades and modifications necessary to satisfy compliance requirements.
But selecting a partner can be daunting. Because regulators consider the computer to be a part of the larger device, it is subject to certification requirements. It must also remain available and supported for the lifetime of the device. And it must also be supportable – meaning that warranty or contract service and repair must be available reasonably close to anywhere the device might be deployed.
