ISO 27001:2022: What Has Changed in the New Revision?
In February of 2022, ISO published a new revision of ISO/IEC JTC 1/SC 27’s ISO/IEC 27002, replacing the 2013 revision, with the expectation that the flagship ISO/IEC 27001 Information security, cybersecurity and privacy protection – Information security management systems – Requirements would also see the 2022 revision published in October. What is ISO 27001? The […]
FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance
21 CFR 820, the regulation that outlines the quality management system requirements for medical devices manufactured or distributed in the US, defines requirements for production and process controls in sec. 820.70 to ‘ensure that a device conforms to its specifications, with 820.70(i) listing the only requirements for software validation in automated processes, something that has […]