ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.īelow you will find the latest stories on ISO 13485 from Med-Tech Innovation News.
We are thrilled to share the news that HealthLink has successfully completed the BSI audit for our ISO 13485. Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. HealthLinks ISO 13485 Certification Renewed. ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485:2016 is a standard that focuses on the importance of the lifecycle of a medical device, including its design, development, production, storage. Forerunners were the EN46001 standard which had to be combined with ISO 9001: 1994.
Certification is issue by the International Organisation for Standardization. ISO 13485 is an international standard in the field of medical devices. ISO 13485:2016 is a regulatory requirement for medical device manufacturers requiring their quality management systems.
