For Class 2 medical electronics, the manufacturing process is part of the regulated product: IPC-A-610 workmanship, lot-level traceability, and validated production lines are conditions of regulatory clearance and sustained field reliability, not optional disciplines. PCI manufactures HealthTech electronics for OEMs across diagnostic, imaging, patient monitoring, and surgical applications, backed by ISO 13485 certification and engineering integrated throughout manufacturing and validation.
Engineering Quality Into Medical Electronics
Medical electronics carry a risk profile that commercial hardware does not. A device that drifts in calibration or fails under sustained operating conditions creates a clinical risk, and that outcome is determined during design and manufacturing, not corrected after deployment.
PCI engages with HealthTech OEMs while their product is still in the design stage, drawing on our manufacturing expertise to advise on component selection, thermal strategy, and workmanship classification from a manufacturability standpoint. This early input helps OEMs avoid design choices that create yield, reliability, or compliance issues once a product moves into production. PCI then verifies the design through functional and automated optical inspection (AOI) testing, confirming the device reaches and holds its specification across a clinical lifetime.
Manufacturing Calibrated to Medical Device Classification
HealthTech hardware spans a wide band of product types: infusion pumps and patient monitoring systems at the higher-criticality end, through in-vitro diagnostics (IVD) equipment, imaging systems, renal dialysis devices, dental instruments, and surgical ancillaries. Manufacturing requirements shift significantly across that range, and the process appropriate for one Class 2 device is not automatically the right one for another.
As an ISO 13485-certified electronics manufacturing services (EMS) provider, we adapt validated production lines, change control procedures, and traceability protocols to the regulatory classification of each programme, giving OEMs manufacturing documentation and build records structured to support their own regulatory submissions.
Our HealthTech Manufacturing Capabilities
- Diagnostic and monitoring devices
- Imaging equipment
- Connected HealthTech
Our Expertise
PCI manufactures HealthTech electronics for OEMs worldwide, across the full range of Class 2 medical device categories:
- Functional and AOI testing: Board-level verification under real operating conditions, covering the test rigour Class 2 device manufacture requires beyond standard power-on functionality checks.
- Lot-level component traceability: Critical components tracked at lot level throughout the build, supporting both internal quality processes and post-market surveillance requirements.
- Documented change control: Change management aligned with regulatory expectations, keeping the build history clean from first-article inspection through production release.
- High-mix, low-volume (HMLV) production: Our Lean Six Sigma flexible manufacturing is suited to the product-variant breadth typical of HealthTech programmes without compromising quality for volume flexibility.