OncoSec Medical has obtained ISO 13485 quality management system (QMS) certification for the design, development, manufacture, and distribution of its electroporation device including the OncoSec medical system (OMS).
Currently being used in three on-going clinical trials, the OMS is used for the treatment of metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.
The OMS has also been used in Europe in Phase IV clinical trials for the treatment of head and neck cancer and cutaneous and subcutaneous skin cancers.
OncoSec Medical president and CEO Punit Dhillon said the ISO certification affirms that the company’s QMS meets the standards and strengthens its commitment to product quality and development.
"With this certification in place, OncoSec is now one major step closer to obtaining the CE Marking necessary for commercialization in Europe," Dhillon added.