ISO 13485 identifies design input requirements. These requirements are: Functional (7.3.2a) Performance (7.3.2a) Safety (7.3.2a) Statutory/Regulatory (7.3.2b) Previous and Similar Designs (7.3.2c) Essential Requirements (7.3.2d) Outputs of Risk Management (7.3.2e) Customer Requirements (7.2.1) Organizational Requirements (7.2.1) Design inputs are supposed…   Read more»