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10 most common mistakes made during risk analysis for medical devices according to ISO 14971 2007/(R)2010 V1

10 most common mistakes white paper

Before marketing of electric or electronic medical devices each manufacturer should conduct a risk analysis. If conducted correctly, the analysis will become useful and will support the manufacturer in the control of product related risks. Otherwise, it will be an unpleasant duty - a task which will swallow up company resources in vain and slow down the process of launching the product on the market.

In this whitepaper there are 10 most common mistakes made during preparation of risk analysis.

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