OncoMark Ltd is pleased to announce that the company’s Quality Management System has been certified to ISO 13485:2016 by leading certification body, BSI.
“This significant milestone is a recognition of our commitment to adopting best practice in design, development and manufacturing here in OncoMark. It demonstrates our ongoing commitment to ensuring that our first product, OncoMasTR, exceeds the strictest quality requirements required in the field. It will facilitate CE Marking and launch of the OncoMasTR test next month” said Des O’Leary, CEO of OncoMark.
“This achievement demonstrates that the product is designed, developed and manufactured to the highest standards and that we are committed to continuous quality improvement” added Dr Sharon Stapleton, Quality and Regulatory Affairs Manager at OncoMark.
Certification affirms that OncoMark complies with the requirements of ISO 13485:2016 and EN ISO 13485:2016 and provides the best quality management system and regulatory compliance for bringing molecular in vitro diagnostic innovations such as OncoMasTR safely to patients.
OncoMark’s lead product OncoMasTR is a multi-parameter prognostic test for early stage breast cancer. The test can determine the probability of recurrence for breast cancer patients, thereby aiding clinicians in determining the best treatment options for their patients and avoiding the costs and severe side-effects from unwarranted chemotherapy, ultimately improving the quality of life of the patient.