We are proud to announce that we are now certified to ISO13485:2016, within the scope of distribution and marketing of medical devices used for interventional cardiology, radiology and neurological procedures.
ISO 13485 is the quality management system standard for medical device manufacturers and their sub-tier suppliers and subcontractors. Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognised as an aid in supporting compliance with the Medical Device Directive.
Our decision to work towards certification demonstrates our commitment to provide a high-quality service to our customers and our ongoing investment in R&D and collaboration around the distribution and marketing of our product portfolio.
Our team have worked tirelessly throughout the certification process, and we are immensely grateful to be successful in achieving this medical device quality standard.