ISO 14971 and ISO/TR 24791 have two main updates this presentation will focus on: foreseeable misuse and active post-market survelliance (i.e. not just relying on customer complaints, but working with the customer to gather data about the product in the marketplace). Usability via the IEC 62366 series of standards has always been parallel to the design and development process, but has rarely been called out with the exeption of novel products. Techniques for usability will help the audience determine foreseeable misuse without needing to go through a formalized, regulated process.
Post market has seen increased emphasis from the FDA in the recent past, which is echoed by the ISO 14971 and ISO/TR 24791 standards. Presenting options on information collection, review processes and activities will help attendees strengthen their post-market systems and provide more value to the customer for production products.