New Product Introductions

Get your new medical device to market faster with the help and experience of Sanbor Medical.

Get across the finish line.

You’ve painstakingly gone from medical device product development to FDA clearance. Sanbor Medical is here to help as you enter the manufacturing stage.

Our experience with NPIs can get you to market quickly

We have manufactured 131 new medical devices over the last five years. Your US-based Project Manager will be with you every step of the way from contract award to First Article Approval, on to Pilot Production Run and eventual  full-volume production.

Business lifetime of IP protection

We’ve been committed to Intellectual Property confidentiality for 30 years. We have never had an IP issue arise and are trusted by several top 30 global medical device companies and many startups.

Strict followers of FDA regulations

Sanbor Medical follows all of the manufacturing and record-keeping requirements per 21 CFR part 820.  We have been audited by the FDA and passed with zero non conformities and are rigorously audited by many leading global medical device companies on a regular basis.

 

A time-tested validation process

Sanbor Medical validates all manufacturing methods and processes as a key element in our device manufacturing, and has passed an FDA audit covering this.

 

Risk Management

We follow the FDA’s protocols and standards for analyzing each step of the manufacturing process and decide on the actions necessary to reduce risk.

See Our Certifications

 

Smarter Manufacturing Starts Here.

Connect with our team to learn how a Sanbor partnership is the future of medical device contract manufacturing.

Connect With Us