Before design work starts, the team decides which quality management system the project runs under: the manufacturer's own, the development partner's, or a new one built for the device. A quality agreement then records which party carries each quality system obligation. The design history file is started from a template, quality system roles are assigned in the development plan, the team is trained on the procedures it will follow, and an approved supplier list is opened.
On the map: Decide whose QMS. Quality agreement. DHF template, QMS roles, training. Start the supplier list.
Rows are disciplines, columns are stages 1 to 8. Select a square to open that task.
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Settle whose QMS governs the work with regulatory and the client before kickoff ends. Train engineering on the procedures they will be audited against.
The manufacturer is legally responsible for the device, so the DHF and the QMS should end up owned inside the company. A startup with no procedures yet often runs the design phase under the development partner's procedures and adopts its own QMS later. A company with a working QMS keeps its own procedures and the partner works inside them. The quality agreement writes down the split.
Each clause names which party fulfils a quality system requirement: design controls, document control, purchasing, CAPA, complaint handling, and who owns the source code and design records. The guidance example of a manufacturer that lost access to contractor source code is the reason ownership of design records is spelled out.
The development plan names who writes, reviews and approves each deliverable, who sets risk acceptability, and who can serve as the independent reviewer at design reviews. In a small team the independent reviewer is someone who did not do the work under review.
Anyone whose output becomes part of the design or its evidence: the software development partner, cloud hosting, data providers, annotation platforms and reader sites. Each needs recorded selection criteria under purchasing controls before their work is relied on.
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