Featured program
Insulin pumps
PCBA and sub-assembly for insulin delivery devices.
PCBA • sub-assembly
MEDICAL DEVICES
Medical Device Electronics Manufacturing
Electronics manufacturing supported by an ISO 13485-certified quality system, FDA facility registration, and 100% component traceability.
• ISO 13485 Certified
• FDA Registered Facility
• 100% Component Traceability
MEDICAL REGULATORY MATRIX
DOCUMENTED
Quality System:
ISO 13485
FDA Establishment:
Registered Facility
Traceability:
100% Component
Assembly Support:
PCBA & Box Build
Documented Quality for Medical Programs
Cal-Comp supports medical diagnostic instrumentation and complex box-build programs. The quality system combines component traceability, incoming inspection, and documented corrective-action processes.
Medical Program Support:
- • Medical diagnostic instrumentation
- • PCBA & SMT assembly
- • Box build & system integration
- • NPI & prototyping support
Quality Protections:
- • 100% component traceability
- • Incoming inspection
- • PCBA and system integration
- • QMS documentation available on request
Medical Manufacturing Experience
The San Diego floor builds insulin-pump and EKG electronics along with finished test instruments, wearable monitors, and diagnostic modules.
Heart-monitoring wearables
PCBA and sub-assembly for wearable cardiac monitoring devices.
COVID-19 test instruments
Finished instruments built in an FDA-registered facility.
DNA test kit module
Module-level build for molecular diagnostic kits.
Vaccine delivery system
COVID-19 vaccine delivery system assembly.
EKG monitors
Patient monitoring electronics.
Bringing a Medical Device to Market?
Talk directly with our sales and engineering team. Program scoping, DFM analysis, and quotes are handled under mutual NDA.
EMAIL OUR SALES TEAM