Once you have established what you are purchasing and what type of supplier you need, it’s time to find qualified partners. The goal here is to plan and implement a consistent, risk-based approach for engaging new suppliers. It is important (and required in ISO 13485:2016) for you to have documented procedures, supplier evaluation and selection criteria, and a record of supplier evaluations you have performed along with subsequent actions. Section 7.4.1 of ISO 13485:2016 combines the words evaluation and selection, […]

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With each passing decade, the world economy becomes more interconnected. It is not unusual for today’s medical device manufacturer to source circuit boards from South Korea, display screens from China, injection-molded components from Mexico, and precision bearings from Germany – all of which are assembled into a finished device in Costa Rica before being sent to the US for distribution all over the world. The geographic dispersion of suppliers, combined with the fact that more device companies are choosing to […]

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