Safety and Cyber Compliance Services

Expert safety certification consulting and support for SIL3 / PLe compliance

Safety Expertise cybersecurity Expertise Expert standards interpretation

Overview

The problem

Certification is where embedded projects stall. Functional-safety and cybersecurity standards are dense, evidence requirements are unforgiving, and a single gap discovered at the final audit can cost months, a hardware re-spin and a missed launch window. Teams that treat compliance as paperwork bolted on at the end learn too late that the evidence an assessor asks for has to be built in from the very first design decision — the architecture, the requirements, the traceability. And for today’s connected products, functional safety and cybersecurity can no longer be handled separately: a safe device that can be compromised over the network is not safe.

What we deliver

End-to-end support through the entire certification journey. We start with a gap analysis and a realistic safety plan, then work alongside your engineers on hazard and risk analysis, requirements traceability, the verification-and-validation strategy, the safety case and the full documentation package an assessor expects. We run pre-audits to surface problems while they are still cheap to fix, and we coordinate directly with the certification body so nothing is lost in translation. Whether you need to reach a target SIL or Performance Level, secure a communication path, or both at once, we make the route explicit and the evidence defensible.

Standards we work to

IEC 61508 as the base functional-safety standard, with its sector derivatives — ISO 13849 and IEC 62061 for machinery, ISO 26262 for automotive, IEC 62304 for medical software, and the EN 5012x series for rail. Safety communication follows IEC 61784-3 (FSoE, CANopen Safety). On the cybersecurity side we align with IEC 62443 and the regulatory pressure of NIS2 and UNECE R155/R156. Your target SIL or PL is set by risk assessment, and every claim is traced back to it.

Proof

More than 30 years in embedded systems, and safety communication stacks independently assessed to SIL3/PLe by an independent certification body — delivered with the very evidence our customers reuse in their own assessments. We are vendor-neutral, so our guidance serves your product rather than a supplier’s catalogue, and our experience is grounded in certifications that have actually been closed, not theory.

Our Services

Pre-Audit & Gap Analysis

Comprehensive pre-audits that identify gaps in your safety documentation and implementation before the formal audit, reducing the risk of failures and costly iterations.

Safety & cyber Documentation Support

Preparation, review and refinement of the extensive safety or cyber documentation certification requires, so it meets the assessor's expectations.

Integrity level Determination

Support in determining the required safety level or Performance Level and interpreting IEC 61508, ISO 13849, IEC 61784-3 and IEC 62061 for your product.

Coordination

Direct coordination with certfification body, drawing on established relationships and knowledge of what assessors look for.

Why Choose ISIT-Neperis

  • Reduced audit iterations
  • Comprehensive documentation review
  • Pre-audit identification of gaps
  • Knowledge transfer to your team

Interested in this expertise?

Request a quote or discuss your project with our engineers.

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