UL Technical Report: 10 most common mistakes made during risk analysis for medical devices according to ISO 14971 2007/(R)2010

Any manufacturer of electrical or electronic medical equipment, before placing it on the market, will face the necessity to perform a risk analysis. Analysis, if carried out correctly, will become a useful document that will help the manufacturers control the risks associated with the product.

If carried out incorrectly, it becomes a tiresome task that consumes resources unnecessarily company and delay the launch of the product.

We have compiled a list of 10 most common mistakes that manufacturers make when preparing for risk analysis.

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