The final assembly of medical devices is only done in environments where there is no room left for error. These products often get assembled, packaged, labeled, sterilized, and are fed into distribution by a single OEM partner, so the level of ultimate trust needs to be extremely high for success.
At Cadence, we offer a dedicated finished device facility in Cranberry Township, PA that has a Certified ISO Class 7 (10,000) Cleanroom for the most extreme final assembly requirements, as well as another Certified ISO Class 7 (10,000) Cleanroom in Alajuela, Costa Rica for additional cleanroom assembly capacity to support new and transfer products for our customers.
Our experienced team and robust quality systems stand ready to help in the final stages of your product development process.
Some of our medical device qualifications include:
- Class 7 (10,000) Certified Cleanroom
- Class 8 (100,000) Certified Cleanroom
- Cleanroom Injection and Insert Molding
- FDA Registered
- ISO 13485
- ISO 9001
Contact us today to find out how WE PUT IT ALL TOGETHER for you!