Medical Device Contract Manufacturing

OSE is an ISO 9001 & 13485 certified and FDA registered global top-ranking Electronics Manufacturing Services (EMS) provider capable of world-class medical device contract manufacturing. We are committed to maintaining compliance in accordance with the most up-to-date regulatory requirements.

Our company uses Manufacturing Execution System (MES) software together with real-time barcode data collection to control product quality and manage documentation for traceability and regulatory compliance. We maintain Device History Records (DHR) as required by FDA regulations. In addition, our Quality System ensures that DHR’s are maintained in accordance with the Device Master Record (DMR).

In most cases, medical device contract manufacturing is high-mix, low-volume (HMLV) in nature. OSE is highly experienced and capable in HMLV production, and offers complete manufacturing services – from PCB board assembly through box-build to testing and fulfillment services. Our team is able to take on projects with turnkey, consignment, or hybrid material sourcing, and our value-added engineering and manufacturing expertise supports the customer design team to identify potential issues prior to the start of production.

With our extensive experience, flexibility and commitment to quality, OSE is your reliable partner that can always be counted on to fulfill your Medical Device Contract Manufacturing needs.