5.2.12 The design document Estimated reading: 1 minute 28 views Authors Purpose and goal Creation of a document with the development results for a product (medical service) as proof that a) the requirements contained in the development submissions are met,b) the subsequent processes for providing the product (service, medical treatment) are suitable,c) all monitoring and measurement requirements, where applicable, and acceptance criteria are included,(d) the evidence on the quality characteristics is sufficient to demonstrate the functionality of the devices for the intended purpose and a safe and proper provision. The scope of the verification documents is defined. A specification sheet, results of the test for technical accuracy and associated user information are attached to the scientific test documents. Application Description of the procedure Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms Attachments 5.2 Analysis and validation - Previous 5.2.11 Examination of the process capability Next - 5.2 Analysis and validation 5.2.13 Innovation initiative
