During the last few years, there has been increased use of agile methods when developing safety-critical systems. This is done to shorten time to market and to reduce costs. Having an agile approach has become even more important due to the new functional safety requirements that are part of automatic and autonomous transports like trains, cars and ships. As a result, manufacturers of sensors and detectors, have to comply with safety standards such as the generic IEC 61508 standard, ISO 26262 for road vehicles or the strengthened requirements for Failure Mode and Effect Analysis (FMEA) in draft prEN 50126:2016for railways. While FMEA traditionally has mainly been a hardware approach, new processes and the increasing use of software diagnostics makes the possibility of an agile approach. The FMEA is a multidisciplinary approach that should start early in the lifecycle and be updated during the whole life of a safety related system. Experience has shown that the FMEA has to be updated before some of the Gate reviews. In addition, we have empirical information about usage of different FMEA approaches at a safety company that has developed SIL 2 products for the last 15 years.