OnCore, your premier medical equipment contact manufacturing partner

IS013485
IQ, PQ, OQ Validation Compliant
Lot and Component Traceability
FDA Registration

OnCore is a premier supplier of printed circuit board and final product assembly services to the medical and life sciences Industries. Our facilities fully support these industries in a true Lean Manufacturing Environment. OnCore has a demonstrated track record of successfully delivering high quality services from design to prototyping, manufacturing to supply chain management.

Our team is fully trained and certified regarding FDA-related standards, and our processes and equipment simplify the delivery of state-of-the-art solutions. OnCore has been a valued partner to a wide variety of leading medical and life sciences manufacturers. Our equipment validation process is in accordance with the FDA QSR. The process is executed for all equipment, whether new or simply moved to a new location. Validations include installation qualification, operational qualification, and performance qualification. Any exceptions found during execution result in immediate process and/or equipment corrections.

FDA Registered Facilities
Class I, II, and III Manufacturing
ISO 85:2003 Certification
ISO 9001:2000 Certification
QSR Part 820 Trained and Compliant
IQ, OQ, PQ Validation Compliant
Lot and Component Traceability
Computerized DFx Tools

NPI services
Complete testing services, ICT, FCT and system Level
Closed loop IT capabilities
Manufacturing Execution System (MES)
Business Process Mapping (BPM)
Integrated Quality System (20/20)
Materials Management System (MMS)

OnCore electronics contract manufacturing
OnCore applies large company technical depth and manufacturing with small company flexibility to all your critical product manufacturing needs.

Full process validation in accordance with the FDA QSR
Automated Design for Manufacturing/Testing Supply Chain (DFX)
ITAR Registered
RoHS and WEEE Compliant
Paperless facility with full lot traceability

OnCore medical and scientific product portfolio

Drug distribution equipment
Patient monitoring equipment
Medical imaging systems
Blood gas analyzers
Bone density scanners
Heart monitoring devices
Clinical diagnostic systems
X-ray equipment
Brain wave monitoring devices
Integrated diagnostic systems

Hospital equipment
Vital signs monitoring equipment
Laboratory freezers
Centrifuges
Research chillers
Anesthesia monitoring equipment
Fast blood pressure check
Laboratory automation
Digital thermometer
Ophthalmology equipment

OnCore Medical/Life Sciences manufacturing resources
OnCore focuses the resources of our five facilities — and our engineering and manufacturing expertise — to each Medical/Life Sciences project we undertake. Contact OnCore today to discuss your contract manufacturing needs.

More information

Click here to read the press release about OnCore's 13485:2003 Medical Certification.

Download a pdf version of OnCore's medical equipment manufacturing capabilities.