Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere. Every international regulatory agency you’ve ever heard of accepts ISO 14971.

ISO 14971 is a good standard: informative, descriptive, and easy (enough) to comprehend. Most important, it’s the risk management standard for the medical device industry.

Let’s do a brief walk-through of the standard in plain language, check out its key definitions and concepts, and break down the ISO 14971 risk management process.

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