Product

Typical product development 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.

The worksheets can be used as a central tool for entering data and content. The worksheet allows viewing access for all team members with controlled access for selected team members to update and modify the content. The data can be exported to standard document forms for approval and filing.