
Obtaining safety certifications and pre-market approvals for safety-related systems is arduous, costly, and prone to failure. And yet such certifications and approvals are integral to the sale and market acceptance of software for a wide range of products. For example, software for a medical device must obtain FDA Class III pre-market approval (IEC 62304), a train control system must meet requirements set out in EN 50126 and EN 50657, automotive system components must meet differing ISO 26262 safety integrity levels depending on functionality, and an industrial automation system is required to be IEC 61508 SIL-rated.
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