Software engineering often demands compliance with specific safety standards. In sectors like medical devices and the automotive industry, safety management activities are mandatory and are in place to minimise the risk of harm throughout the project lifecycle.
We cover all phases of the software safety lifecycle; from safety planning and hazard analysis through to requirements, verification and validation, to the preparation of a safety case or a design history file.
We have a deep understanding of the safety standards required to deliver software in key sectors, including but not limited to ISO 13485, IEC 62304, ISO 14971, FDA in the Medical Industry; IEC 61508, RTCA DO-178B/C, DefStan 00-56, 00-55 in Defence and ISO 26262 & MISRA in the Automotive sector.
We also cover different safety integrity levels up to and including the highest level: SIL 4.
We have utilised various tools and methods for safety-related software projects and use Industry standard processes such as FMEA, fault-tree and hazard/risk analysis to ensure we help our clients overcome safety management challenges.