When purchased products arrive at your facility, you need to confirm that they meet the requirements established in your quality agreement. What’s the best way to go about that?

First, consider the risk associated with the purchased product and then examine any actions the supplier has already taken to verify compliance. Choosing the right verification method is a risk-based decision and there are a variety of methods available.…

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Spotty quality. Price increases. Poor reliability. There are myriad reasons why medical device suppliers go from “approved” to “disqualified” on your Approved Supplier List.

Regardless of how many suppliers you have, it’s important (and required) that you monitor their performance and conduct regular evaluations. This will allow you to make informed business decisions, spot performance issues before they worsen, uncover waste, and facilitate supplier performance.…

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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.…

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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.…

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