ISO 13485:2016 Procedure - Planning of Product Realization - describe the planning of for all product realization processes. When you add a new process or product, how do you identify quality objectives, product requirements, process characteristics, and determine control of the process? Identify responsibility for deciding what work instructions are and records are required.
ISO/IEEE International Standard - Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature AMENDMENT 1: Additional definitions
ISO/IEEE International Standard--Health informatics--Device interoperability--Part 10206: Personal health device communication--Abstract content information model
