The key to a successful NPI or Product Transfer to a contract manufacturer lies in a strategic, well-choreographed project management system.
Your assigned US manufacturing project manager will handle all aspects of NPI or product transfer, all the way from initial review of engineering and design through customer approval of the First Article and Pilot Production runs.
Sanbor Medical provides you with a significant stateside interface, saving you the inconvenience of dealing with a factory half a world away. With manufacturing project management, sales and customer service based in our headquarters in Allentown, PA, you can interface on your projects with technical and support personnel in your time zone and in your language.
Our cross-functional, overseas team manages our suppliers while handling manufacturing and operations, manufacturing engineering, project management, global logistics, sourcing and purchasing to ensure quality, on-time delivery and service.
DMR + DHR
Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.
We pride ourselves in maintaining accurate records according to the FDA’s 21 CFR Part 820 regulations. From Purchase Order to Shipping, the entire manufacturing history; including procedures, specifications and production history of the device, is documented and maintained.
Risk Management
We follow the universal Risk Management Guidelines and analyze and evaluate each manufacturing process to ensure the very best in operations and compliance
Method and Process Validation
We understand that validation is a key element in medical device manufacturing. We have passed an FDA audit which included testing this very complex process.
Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.
We pride ourselves in maintaining accurate records according to the FDA’s 21 CFR Part 820 regulations. From Purchase Order to Shipping, the entire manufacturing history; including procedures, specifications and production history of the device, is documented and maintained.
We follow the universal Risk Management Guidelines and analyze and evaluate each manufacturing process to ensure the very best in operations and compliance
We understand that validation is a key element in medical device manufacturing. We have passed an FDA audit which included testing this very complex process.