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Dual sourcing reduces supply risk but doubles qualification and change control effort, and two convertingConverting is the process of transforming raw materials—such as films, foils, papers, foams, fabrics, and adhesives—into finished or semi-finished products through specialized manufacturing processes. processes can produce measurably different parts. It is most often justified for high-volume or supply-critical components. Where dual sourcing is used, both suppliers should be qualified against the same baseline and specification. Advantage Converting can also support dual-source strategies through its two manufacturing facilities, providing an additional option for production continuity and supply-risk planning.

A bridge build, or last-time buy, is inventory purchased from the outgoing supplier to cover production while the new supplier is qualified. It should be sized to cover tooling, material lead times, qualification, internal approvals, and a contingency for a failed first article — not just the expected best-case timeline.

It depends on the device and the change. Medical device manufacturers evaluate supplier changes under their own quality system — ISO 13485:2016ISO 13485:2016 is an international quality management standard for organizations involved in the design and manufacture of medical devices. and, in the United States, FDA’s Quality Management System Regulation (21 CFR Part 820). Some supplier changes can be managed internally through change control and supplier qualification; others may affect regulatory filings. That determination belongs to the device manufacturer’s regulatory team.