ISO 13485:2016 & EN ISO 13485:2016 Certification
CIS Oncology is pleased to announce that the company has achieved ISO 13485:2016 & EN ISO 13485:2016 certification following an audit by BSI, the UK’s national standards body. ISO 13485:2016 is the internationally recognised quality standard to ensure the consistent design, development, installation and support of medical devices.
Chris Short, Head of Product Management commented “This certification represents an important milestone for the company. It reflects its commitment to safety and to providing a high-quality product and shows the focus that the company has on risk-based decision making throughout the organisation. Through this standard CIS Oncology will be able to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of software as a medical device”. ChemoCare v6.05 is registered with MHRA under the Council Directive 93/42/EEC as a Class I medical device.
This latest certification will add to the company’s existing ISO portfolio which includes ISO 9001:2015 and ISO 27001:2013.