Cortland's facility in upstate New York USA, is a 13485 registered facility. The notified body that provides our certification is DNV business assurance (det norske verities). Cortland has certified clean room manufacturing areas, as well as areas rated as controlled environments.
- The cleanrooms at Cortland are designed and certified to meet at least ISO Class 8 requirements as specified in ISO 14644; "Cleanrooms and associated controlled environments" - Parts 1, 2, 3 and 5.
- The cleanrooms also comply with the microbiological requirements in ISO 14698; "Cleanrooms and associated controlled environments - biocontamination control" Parts 1 and 2.
Cortland’s manufacturing services include, but are not limited to, the design and manufacturing of complex braids and fabricated assemblies using the latest medical materials. Our engineers design custom solutions to meet the rigorous demands of your device or procedure. In doing so, we not only take into account your required performance characteristics, but also the clinical application to ensure the design is robust for optimal performance and is of the highest quality.
Cortland’s manufacturing capabilities also allow for secondary operations to be conducted, supplying the braid as an assembled component. Our braiding operations are conducted in either the controlled environment or the clean room, depending on the requirements of the customer.
Cortland operates under the design and control guidance of 21 CFR part 820. This service ensures that the product developed meets the design criteria established up-front by our customer, with input from Cortland. The documentation generated ensures product performance required to support your FDA or European filing.