One of the challenges in risk analysis of medical devices is the diversity of use scenarios based on the target medical purpose and use environments. That is why ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices, requires that risk analysis begin with a clear understanding of the intended use and reasonably foreseeable misuse.
Read MoreRisk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices. As outlined in Clause 5.1, the manufacturer shall perform risk analysis for the particular medical device as described in clauses 5.2 to 5.5. Here is how a Preliminary Hazard Analysis (PHA) can help.
Read MoreThese terms are foundational to risk analysis, yet they are poorly understood and often incorrectly applied.
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