Objective evidence to support your personnel through the design, development, manufacturing, and support of medical devices. Documentation is key for objective evidence. ![]() In essence, everything revolves around documenting statements, required procedures, and records, including all the essential documents for planning, operation, and control of the organization’s process. In this QMS world, there is an already known saying that says: “… if it isn’t documented like it didn’t happen.” Everything has to be documented, so it can be tracked. ![]() If not in this part then by the end you will perceive the importance of documenting practically everything. ![]() ![]() You will see in the end, it’s all about documentation.
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