specifications;
- Production processes, including infrastructure requirements, production equipment requirements, production methods, special processes;
--Quality assurance procedures and specifications, including acceptance guidelines and measurement equipment to be used;
--Packaging specifications, including methods and processes;
--Description of intended use/purpose;
--Design outputs for compliance with medical device regulatory requirements;
--Risk management records, including risk analysis, risk reduction measures, residual risks incurred and risk/benefit analysis;
--Marking, including any instructions for use;
--Procedures and guidelines for product maintenance;
-Applied unique device identifiers (UDIs);
-Documentation of changes in the language version in which the medical device can be used;
-Clinical information;
- information relating to the biosafety and biocompatibility of the materials and components that make up the medical device;
- verification or validation of changes to the performance and characteristics of the medical device over the life cycle of the medical device information;
- storage and transportation requirements;
- description of accessories, other medical devices or non-medical devices, that are expected to be used in conjunction with the medical device;
- -Standards and other methods used to demonstrate compliance with safety and performance requirements;
-Methods for demonstrating compliance with each generic safety and performance requirement;
-Identification of documents that provide safety and performance requirements;
--Methods for demonstrating the accuracy of any measurements;
--Identification of medical device products that contain pharmaceutical ingredients or human or animal tissues, and confirmation of the safety, efficacy, and usability of these contained substances