Entries by Conny Östlund

Functional Safety according to IEC 61508

A customer designing and manufacturing a protection system for high loads on cranes and lifting devices need to establish the achieved functional safety for the protective system. Requirements Perform reliability prediction and an FMEDA analysis in line with IEC 61508 in order to establish the following parameters: Safe Failure Fraction (SFF) Diagnostic Coverage (DC) Analysis Based on […]

Reliability Evidence Report, 510(k)

A European manufacturer of medical equipment was planning to bring products to the American market. They needed to demonstrate that the product, although it had been on the European market for many years, that it had a controlled reliability. This was done in a Reliability Evidence Report. Requirements Section 510(k) of the Food, Drug and Cosmetic […]