- Manufacturing Services
- About Us
You’ve painstakingly gone from medical device product development to FDA clearance. Sanbor Medical is here to help as you enter the manufacturing stage.
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.
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.
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.
Sanbor Medical validates all manufacturing methods and processes as a key element in our device manufacturing, and has passed an FDA audit covering this.