During 2022, one of Basis Technologies’ existing customers requested their external auditors perform an audit of ActiveControl and Basis Technologies’ DevOps (Development, Quality Assurance, Support) Team processes in line with the requirements of ISO 13485:2016.
This particular customer operates within the life science / medical device industry. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The feedback from this external Audit was extremely positive. Only two minor items were highlighted, which the customer’s Auditors said was extremely praiseworthy for a company of Basis Technologies size. For the two minor items (both of which were internal procedural in nature, and not related to the ActiveControl product itself), Basis Technologies are already putting in place the necessary action plan to mitigate.