MDSAP Chapter 5 — Design and development

Chapter 5 asks the auditor to pick a finished design project and walk planning, inputs, outputs, verification, validation, risk, changes and transfer. HAVGATE loads those tasks. It is not a design-history authoring tool.

The product includes tasks 5.1 through 5.17: identifying devices subject to design control, selecting a project, planning, implementation, inputs, whether inputs are complete, outputs and verification, risk through the project, confirmation that risk controls work, design validation, clinical or performance evaluation, software design, change, design review, the effect of a change on devices already distributed, design transfer, and management commitment.

If your company has no design activity, your procedure should say so and your audit plan should say so. If you do, the auditor will ask for one file, not a slide. HAVGATE records the task outcome against that project. The drawings, the risk file and the verification reports stay where you already keep them, or in document control if you choose to control them there.

Do not read this chapter as a claim that HAVGATE includes design-control authoring software. The tasks record the outcome of a design review. They do not write the design history file.

The working checklist is the full 5.1 to 5.17 set inside /mdsap-audit-checklist and in the product, not a PDF. Grades, when you assign them, are explained on the grading page. Confirm the current audit approach document before you treat a task title as the only criterion.