In December 2014, HydraBrush Inc. successfully re-certified its ISO 13485 standing. We have been certified since January 20, 2009 for the
successful registration of our Quality Management System for its power toothbrush and brush heads to the ISO 13485:2003 Standard.
Click here to view / download the certificate.
In addition, a Medical License has been awarded by Health Canada. This license reflects HydraBrush, Inc.'s adherence to the requirements of the Canadian Medical Devices Conformity Assessment System (CMDCAS). The Canadian Medical Device Regulations require compliance with ISO 13485:2003 as well as regulations specific to Canada. Registration and certification was awarded by the British Standards Institute (BSi).
The initial registration followed an intensive audit of the Company's quality management system, performed by a representative of BSi through the latter half of 2008. The BSi auditor examined the Company's quality policy, objectives, operating procedures, record keeping, and interviewed on-site staff. "We are elated and proud to achieve the 13485 certification, as it demonstrates that our quality management system can produce medical devices that meet the applicable regulatory requirements and our customers' needs," said Ken Hegemann, HydraBrush President and CEO. "The certificate conveys to our customers and the financial community that we have a system in place that demonstrates our total commitment to the highest standards of quality control. This significant accomplishment enables us to provide the international market with the latest advancements in oral care. Certification to 13485 and the Canadian regulations adds value to our marketing efforts, and puts us in a ideal position to realize commercial adoption of our products internationally."