Top

Carrot Medical Announces ISO 13485:2016 Certification

Carrot Medical – the leader in interventional cardiology & radiology lab solutions – has been an ISO 13485 compliant company for nearly a decade. The ISO standard specifies the requirements for comprehensive quality management systems (QMS) in the design and manufacture of medical devices.

Carrot Medical’s annual audit – performed by British Standards Institution (BSI) – occurred on October 2nd, 2018. Following the audit, Carrot has been recommended for recertification to the new international standard ISO 13485:2016, for medical device quality management systems.

“Having an ISO 13485:2016 quality system means that we have certified processes which enable us to innovate quickly and safely allowing us to bring state-of-the-art solutions to our customers,” said Jeremy Wiggins, Carrot Medical CEO.

“The ISO 13485:2016 is the latest update to the standard’s requirements, previously revised in 2003. This revision expands risk management, adds new safeguards, and outlines new policies for control in supply chain management. ISO certification confirms to Carrot Medical’s customers and patients that Carrot develops and manufactures with world-class quality management systems and regulatory compliance for its products and services.”