July 19, 2021 Risks from an Inadequate Development Process for Software The most fundamental reason for medical device design and development controls (e.g., ISO 13485 clause 7.3; the U.S. FDA’s 21 CFR 820.30, etc.) is to control risks that come from an inadequate development process. That fact is unequivocally true and stands in stark contrast to […]
<h1 class="entry-title">Category: ISO 14971</h1>
ISO 14971 Estimating Probability of Occurrence of Harm
July 13, 2021 ISO 14971 Estimating Probability of Occurrence of Harm Based on the aforesaid flexibility (see my earlier blog post) allowed by ISO 14971 (e.g., see the third paragraph of ISO/TR 24971 section 5.5.2) for how to estimate probability of occurrence of harm, one might employ a variety of probability expressions. For example, […]
ISO 14971 Probability of Occurrence of Harm
July 12, 2021 ISO 14971 Probability of Occurrence of Harm When tackling the estimation of probability of occurrence of harm during medical device risk management, I think it is important to remember that there is no one-size-fits-all approach. Instead, each manufacturer’s approach needs to be derived and appropriate based on the nature and complexity […]