Quality Management

At Precision BioLogic, quality is more than a role carried out by a few specialists; rather, it is inherent throughout our organization.

Our organization works cross-functionally with our Quality team to identify, develop, monitor and control processes that ensure the quality and reliability of our products and services. We continuously work to make our standards and processes second to none. As a result, our internal Quality Management System is registered to ISO 13485.

ISO Certificate of Registration

Our commitment to quality doesn’t stop there, however. Our CRYOcheck™ medical devices are manufactured to CGMP under the FDA’s Quality System regulation and they are cleared for sale in the United States, Canada, the European Union and Australia.

  • Precision BioLogic has a quality product. We have done validation crossover testing with other companies that provide frozen coagulation products and the results have always indicated that we should continue to use Precision BioLogic products.

    -N.A.F., Technical Leader, Gundersen Health System