Document

Document logs include development plans/checklists, user feedback, concept diagrams, design reviews, FMEA's/risk management, requirements, specifications, bill of materials, device master records, software, drawings, test reports, verification and validation protocols/reports, development bugs, and reworks. The logs can provide a quick reference to the various documents generated for each module, improve communication/visibility among team members during the product development process, and provide a cross-check/reference when preparing for design reviews, design history files, and regulatory submissions [e.g., technical files, 510(k)s]. The logs can be filtered to show key fields (e.g. approved vs. assigned status) and other fields as applicable.