OncoSec Receives ISO 13485 Quality Management System Certification

OncoSec Receives ISO 13485 Quality Management System Certification

30 July 2012,   By ,   0 Comments

SAN DIEGO, CA — July 30, 2012 OncoSec Medical Inc. (OTCBB:ONCS), which is developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers, announced it has received notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices”. The certification confirms the company’s Quality Management System (QMS) and that the company’s manufacturing processes are controlled, documented and compliant with the stringent requirements set by the European Union.

“The ISO certification is a significant accomplishment and an important milestone for OncoSec. Certification affirms that our QMS meets the highest standards and strengthens OncoSec’s commitment to product quality and development,” said Punit Dhillon, President and CEO. “With this certification in place, OncoSec is now one major step closer to obtaining the CE Marking necessary for commercialization in Europe.”

Companies receiving the ISO 13485 certification must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of OncoSec devices, as well as, the company’s commitment to continuous improvement. OncoSec’s review was performed by SGS, a world leader among notified bodies in inspection, verification, testing, and certification.

OncoSec’s electroporation device, the OncoSec Medical System (OMS), is currently being used in three on-going clinical trials for the treatment of metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. In addition, the OMS has been used in Europe in Phase IV clinical trials for the treatment of head and neck cancer and cutaneous and subcutaneous skin cancers.


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