Step 2. Integrated Safety & CE Marking Readiness
We address safety requirements across all SAIL and DAL, and lay the technical foundation for CE Class Marking.
Specific Operation Risk Assessment (SORA)
Conducting the complete SORA methodology (as per EASA AMC1 Article 11) when STS/PDRA are not applicable, including Ground & Air Risk analysis, SAIL determination, and definition of Operational
Safety Objectives (OSOs).
Risk Assessment per ISO 12100 and CE Marking
The mandatory technical foundation for CE Class Marking (C1–C6). We demonstrate compliance with Essential Health and Safety Requirements (EHSR) under EASA Regulation 945/947, so your product arrives at the Notified Body ready for first-pass approval.
Safety Assessment Process (ARP 4761A)
Implementing tailored safety analyses (FHA, PSSA, SSA, FTA, FMEA/FMECA, CCA) scaled to the identified risk level (SAIL) and OSO requirements.
Safety Requirements Management
Defining, deriving, and managing the safety requirements necessary to meet the required integrity and assurance levels.
RAMS Analysis
Performing Reliability, Availability, Maintainability, and Safety analyses to substantiate the safety case and support design choices.
