ISO 13485 LI Practice Questions - PECB Certified ISO 13485 Lead Implementer Exam

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ISO 13485:2016 Clause 4.1.1 requires the organization to document the role(s) it plays in the supply chain. Which of the following BEST describes those possible roles?

Manufacturer only Manufacturer, authorized representative, importer, or distributor Designer only Distributor or importer only

Correct Answer:

Manufacturer, authorized representative, importer, or distributor

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