2021 has been a dense year for Copan Wasp Regulatory and Quality departments. In view of many other significant deadlines to be met in 2022, let’s recap what we recently achieved:
- Medical Device Single Audit Program (MDSAP). MDSAP allows recognized Auditing Organizations to conduct a single regulatory audit of a medical device manufacturer to assess compliance with regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan, and the US. On January 7, 2022, Copan Wasp received its MDSAP certificate.
- In Vitro Diagnostic Regulation (IVDR) compliance. Copan WASP is committed to managing the important transition to the IVDR actively and promptly. Our Class A products are already registered in the EUDAMED database, and our Quality Management is compliant with the new IVDR, meeting the stricter quality, safety, and reliability requirements.
- Colibrí™ 510(k) Clearance. In December 2021, the sample preparator Colibrí™ was certified by the FDA, which affirmed the safety and performance of the device. As a result, the Colibrí™ system is now available for US laboratories to prepare MALDI-TOF targets for ID.
We still have many things in the pipeline, such as the IVDR certification for our non-A class devices and the 510(k) clearance of Colibrí™ for its use for Antibiotic Susceptibility Testing.