Menlo Park, CA (March 2, 2015)–RenovoRx, a leading developer of innovative solutions for targeted delivery of fluids to selected sites in the vascular system,today announced that it has achieved ISO 13485:2003 certification, an internationally recognized quality standard for medical devices. BSI (the British Standards Institution) awarded the certification.
ISO 13485:2003 specifies requirements for medical device quality management systems. Companies must demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services. The ISO 13485:2003 certification is generally the first step toward obtaining the CE mark, the regulatory clearance recognized in Europe and other countries that indicates that products meet EU safety, health or environmental requirements.
“We are introducing the RenovoCath RC120™ to the clinic now, and we are pleased to be starting off with the ISO quality certification,” said Shaun Bagai, Chief Executive Officer. “Achieving the ISO 13485:2003 certification shows that we are committed to delivering quality products and continually improving our processes.”