Verisante Technology Inc has completed the certification process for quality management standard ISO 13485:2003 for medical device manufacturing. Verisante’s quality management system was audited and assessed by BSI Group. BSI is a recognized registrar under the Canadian Medical Devices Conformity Scheme, designated as a Notified Body under the Medical Devices Directive for Europe, and designated as a Conformity Assessment Body under the Mutual Recognition Agreement between the European Union and Australia.
The company is also attempting to obtain a CE Mark for both European and Australian regulatory approvals this year for the Verisante Aura™, a noninvasive device that uses proprietary technology to assist a medical professional in detecting skin cancer. Verisante has engaged Emergo Group Inc as its authorized representative in Europe to act as the point of contact for inspection authorities and to assist in device registrations and reporting.