Kasve’s experts are qualified to perform audits on ISO 13485 compliant activities (lead auditor and internal auditor qualifications). In addition, we help you to consider the requirements of local legislation as part of the processes of the quality management system. Your organization will get support in defining and developing, in identifying and describing the processes, in development activities and in auditing of your quality management system. Kasve’s experts have been involved in developing, updating, and auditing several quality management systems of medical device manufacturers and distributors to ensure compliance with the ISO 13485 standard. Kasve’s ISO 13485 services for our customers’ needs FDA is also harmonizing its requirements to comply with the ISO 13485:2016 standard. The ISO 13485:2016 standard is harmonized with the EU legislation on medical devices and in vitro diagnostic medical devices, which means that by following the standard, the organization meets the specific requirements of the legislation. EN ISO 13485:2016 harmonized with EU legislation (MDR and IVDR)
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