Why it is Required to have Document Control ? It is required by both FDA (in Federal, Food, Drug, and Cosmetic Act) and European Community (in ISO 13485) Has always been a requirement, from 1976 (GMPs) and 1996 (ISO) Cited regularly by both FDA inspectors and notified body auditors as deficient Often ignored by upper Read more about Document control as per ISO 13485[…]
FDA regulatory requirements as follows Most of the complex medical device instruments require premarket notification [510(k) or even a PMA (premarket approval) 510(k) and PMA Guidance Documents include requirements for reprocessing instructions for the user: Detailed cleaning instructions, including disassembly. Detailed disinfection & sterilization instructions with specific sterilization parameters. Expected end of life & how Read more about Cleaning validation and Labelling Requirement for reusable medical devices[…]
Though the word USE error is not used officially. The definition of USE error is “Act or omission of an act that results in a different outcome than intended by the manufacturer or expected by the USER, which may result from a mismatch situation between USER, man-machine interface, task and/or environment.” AAMI HE74:2001 Many research Read more about USE error and medical device recall[…]
FDA regulatory requirements Most of the complex medical device instruments require premarket notification [510(k) or even a PMA (premarket approval) 510(k) and PMA Guidance Documents include requirements for reprocessing instructions for the user: Detailed cleaning instructions, including disassembly. Detailed disinfection & sterilization instructions with specific sterilization parameters. Expected end of life & how this can Read more about Cleaning validation and Labelling Requirements for reusable medical devices[…]
Data Governance provides a framework for dealing with the challenges around data compliance and regulation which aids in the management of the availability, usability, integrity, quality, consistency, and security of the data employed in an enterprise and helps organizations meet compliancy with legislative laws, regulations, and mandates. Data Governance Framework Organization : It requires representative participation Read more about How to Create a Data Governance Framework for Data Integrity[…]