Verisante Technology, a provider of cancer imaging technology, has received ISO 13485:2003 certification for its quality management system.
The certification was audited and assessed by BSI Group.
BSI is a registrar under the Canadian Medical Devices Conformity Scheme, designated as a Notified Body under the Medical Devices Directive for Europe.
It is also designated as a Conformity Assessment Body under the Mutual Recognition Agreement between the European Union and Australia.
The company plans to obtain European approval by Emergo Group and also Australian regulatory approval this year.
Verisante Aura is a non-invasive device that uses proprietary technology to assist a medical professional in detecting skin cancer instantly, providing immediate and accurate results