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
Escondido, CA (PRWEB) April 2, 2009
On January 20, 2009, HydraBrush Inc. received certification for the successful registration of its Quality Management System for its power toothbrush and brush heads to both the ISO 13485:2003 standard, and 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.
The 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.
On March 2, 2009, HydraBrush Inc. was officially granted a Medical Device License by Health Canada. HydraBrush is considered a Class 2 medical device in Canada, thus a license is mandatory prior to entering the market.
"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 ISO 13485 and obtaining the Canadian Medical Device License adds value to our marketing efforts, and puts us in an ideal position to realize commercial adoption of our products internationally."
About HydraBrush Inc.
Vision: to revolutionize the way people care for their teeth by providing exceptionally innovative products that are fast, effective, easy to use, and have a profound/positive impact on the oral health of people worldwide.
HydraBrush Inc. manufactures and distributes state-of-the-art powered toothbrushes that virtually automate proper and thorough brushing of the teeth and gums. HydraBrush Inc.'s core technology is an advanced configuration of eight microbrushes that surround the six surfaces of the teeth simultaneously. The clinically proven technology eliminates human error to provide proper oral care in 40 seconds or less - 1/3rd the time required by all other power toothbrushes. For additional information, please visit: http://www.hydrabrush.com
For further information, please contact:
Bill Dendiu, CMO/Public Relations
Email: bdendiu54 (at) cs (dot) com
Phone: (888) 813-6631
Email: info (at) hydrabrush (dot) com
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