Contract Cleanroom Assembly and Packaging
An ISO and FDA Registered Facility: ISO 13485:2016 | FDA Registered 2032092
SpecialTeam is an ISO 13485:2016 registered facility that provides comprehensive assembly and testing of medical devices.
Our assembly and manufacturing capabilities include dedicated assembly cleanrooms, in process, and testing capabilities.
To assist us in maintaining a reputation for product quality, we ensure that our supplier network is extensive and consists of highly rated vendors.
The manufacturing of medical devices at SpecialTeam includes the precision assembly of various devices with varying complexities.
Combined with temperature and humidity controlled capacity, our tightly controlled Class 1000 (ISO Class 6) cleanrooms can provide the required conditions for nearly every product.
We also have a Class 10,000 (ISO Class 7) cleanroom for products not requiring such strict environmental control.
All assembly is performed by a staff that has extensive training and experience processing disposable medical devices within a cleanroom environment.
All assembly processes are controlled by documentation that are product/client specific and all processes are approved by the client prior to the first production start up.
Any changes to the assembly processes are pre-approved by the client.