Incap has active medical and laboratory production across several sites including Estonia, Slovakia, Incap Germany and Romania, the UK, and the US. Products range from individual PCB assemblies and sensor modules through to complete electromechanical builds and box build assemblies for diagnostic, monitoring, and laboratory applications.

The production scope for medical devices often requires more than standard assembly. Calibration, functional testing under defined conditions, clean-room compatible assembly where required, and protection processes such as conformal coating and potting are all part of the build depending on the application. Incap’s mechatronics capability also covers more complex assemblies where electronics, mechanics, sensors, and cabling need to work together as one tested unit.

ISO 13485 is held across multiple Incap sites, covering the quality management requirements for medical device manufacturing. The quality system, process controls, documentation, and traceability practices are already in place. Customers do not need to build them from scratch with a new supplier.

Traceability at component and process level, validated test methods, controlled change management, and complete production documentation are standard practice in Incap’s medical production. For products that go through regulatory submission, the manufacturing record needs to support that process, and Incap structures production accordingly from the NPI stage.

Medical device projects typically require careful progression from design validation through pilot builds and production release. Incap’s NPI process covers DFM and DFT review, prototype builds, first article inspection, process validation, and the creation of a full production documentation package before series production begins. This structured approach reduces the risk of issues that would be costly to resolve after regulatory submission.

For products with long market lives, component obsolescence management and continued manufacturing support are equally important. Incap manages these proactively as part of the ongoing production relationship.

For a medical device manufacturer, the choice of EMS partner is a quality system decision as much as a manufacturing one. The partner’s processes, documentation, and traceability practices become part of the product’s regulatory record. Incap’s ISO 13485 certified production across multiple sites means that the quality framework is already in place, independently audited, and maintained. This reduces the qualification burden for new customers and new products.