TECHNOLOGY — Technology

Functional Safety & Certification

ISO 26262, IEC 61508, IEC 62304, ASPICE — we engineer safety into the architecture, not bolt it on afterward. From hazard analysis through certification body audit, with full requirements traceability.

OVERVIEW

Safety by Design, Not by Retrofit

Functional safety certification is the single largest barrier to market entry for safety-critical embedded products. ISO 26262 alone requires 12-24 months of systematic engineering — hazard analysis, safety concept development, hardware/software architecture design with proven fault detection mechanisms, unit and integration testing against safety requirements, and external audit by TUV, UL, or equivalent certification bodies.

Promwad integrates functional safety engineering into the development process from day one. Our safety engineers work alongside hardware and software teams to ensure that safety requirements are traceable through architecture, implementation, and verification. This "safety by design" approach is consistently faster and less expensive than retrofitting safety onto an existing design — which typically requires 40-60% rework.

ISO 26262 ASIL-B/C: automotive functional safety from concept through production
IEC 62304 Class B/C: medical device software lifecycle compliance
IEC 61508 SIL 2/3: industrial functional safety for process control and machinery
ASPICE v4.0 CL2: automotive software process improvement and capability assessment
ISO 21434: automotive cybersecurity engineering and threat analysis (TARA)
CE/FCC/RED regulatory compliance: EMC, radio, and safety directive conformity
UNECE R155/R156: vehicle cybersecurity and software update management
Hazard analysis methods: FMEA, FTA, HARA, STPA for complex systems
ANONYMIZED PROJECTS

Selected Safety & Certification Projects

ISO 26262 ASIL-B Certification for 360-Degree Truck Camera

Led the functional safety workstream for a 6-camera surround-view system targeting commercial trucks. Performed HARA, developed the technical safety concept, designed ASIL-B decomposition across FPGA (AMD Zynq) and MCU (NXP S32K), implemented safety mechanisms (watchdog, ECC, redundant paths), and supported the TUV audit.

OUTCOMEASIL-B certified on first audit attempt. ASPICE CL2 process audit passed concurrently.

IEC 62304 Class C for Patient Monitoring Device

Implemented the complete IEC 62304 software lifecycle for a European medical device company's patient monitoring system. Covered software development planning, requirements management (Polarion ALM), architecture design with risk analysis per ISO 14971, unit testing with MC/DC coverage, and integration/system testing. Prepared the technical file for MDR submission.

OUTCOMECE marking achieved. Technical file accepted by Notified Body without major findings.

SIL 2 Safety System for Battery Energy Storage

Designed and certified a SIL 2 independent safety layer for a BESS installation. The system implements dual-channel disconnect logic with self-diagnostics, multi-sensor fusion (gas, temperature, BMS telemetry), and a fireproof data recorder. Followed IEC 61508 lifecycle with systematic capability assessment.

OUTCOMESIL 2 certified. Sub-100ms thermal runaway response time. Deployed across 15 BESS sites.

Client identities changed. Methodologies and outcomes are real.

ENGINEERING STACK

Safety Engineering Stack

Safety Standards
ISO 26262:2018 (ASIL-B/C), IEC 61508:2010 (SIL 2/3), IEC 62304:2006+A1 (Class B/C), ISO 13849-1:2023 (PLd/PLe), DO-178C (DAL C)
Process Standards
ASPICE v4.0 (CL2), ISO 21434 (cybersecurity), UNECE R155/R156, ISO 14971 (medical risk management), IEC 62443 (industrial cybersecurity)
ALM & Traceability
Polarion ALM, IBM DOORS, Jama Connect, codebeamer. Bidirectional traceability: requirements → architecture → implementation → test → evidence
Verification & Validation
Static analysis (Polyspace, LDRA, PC-lint), unit testing (VectorCAST, GoogleTest), MC/DC coverage, HIL/SIL/MIL simulation (dSPACE, NI)
Safety Analysis Tools
FMEA (APIS IQ), FTA (FaultTree+), STPA (MIT methodology), HARA worksheets, DFA analysis, FMEDA for hardware metrics
Regulatory Compliance
CE marking (EMC Directive 2014/30/EU, LVD 2014/35/EU), FCC Part 15, RED 2014/53/EU, UKCA, pre-compliance EMC testing with near-field probes
REFERENCE ARCHITECTURES

Reference Architectures

IEC 61508 SIL Architecture

Sensors
Safety Logic Solver
Actuators
Diagnostic Coverage
Safety Lifecycle

SIL 2/3 safety instrumented system with dual-channel sensing, self-diagnostics, and proven-in-use actuator logic per IEC 61508.

Redundant sensor inputsSafety PLC / MCUWatchdog timerSafe output driversFMEDA analysis

Automotive ASIL-D

Redundant Sensors
Safety MCU (Lock-step)
Actuator Monitoring
Fault Reaction
Safe State

ASIL-D compliant architecture with lockstep MCU, redundant sensor paths, independent fault monitoring, and defined safe states per ISO 26262.

NXP S32K3 lockstepDual-channel ADCIndependent watchdogSafe power supplyDiagnostic coverage >99%
CREDENTIALS

Our Safety Credentials

ISO 26262 ASIL-B/C Certified Project DeliveryASPICE v4.0 CL2 Aligned ProcessesIEC 61508 SIL 2/3 Safety System DesignIEC 62304 Class C Medical SoftwareISO 21434 Automotive CybersecurityISO 9001:2015 Quality ManagementTUV and UL Certification Body RelationshipsClutch 4.8/5 Rating
FREQUENTLY ASKED

How much does functional safety certification add to project cost?

When integrated from the start ("safety by design"), functional safety adds 20-40% to the base development cost. Retrofitting safety onto an existing design typically costs 60-100% more than the original development and takes 12-18 months longer. The single largest cost driver is rework — changing architectures and interfaces that were not designed for fault detection.

Can you certify our existing product, or do we need to redesign?

We start with a gap analysis against the target standard. Some designs can be certified with targeted modifications — adding safety mechanisms, improving test coverage, completing documentation. Others require partial or full redesign if the architecture fundamentally cannot meet diagnostic coverage or fault detection requirements. The gap analysis typically takes 4-6 weeks and gives you a clear decision.

Which certification bodies do you work with?

We have established working relationships with TUV SUD, TUV Rheinland, UL, and SGS for functional safety audits. For CE/FCC compliance, we work with accredited test laboratories across Europe. We manage the entire certification body interaction — from initial scope agreement through final audit support.

Do you handle CE/FCC compliance in addition to functional safety?

Yes. Regulatory compliance (EMC, radio, electrical safety) is a separate workstream from functional safety but often runs in parallel. We handle pre-compliance testing, design modifications for EMC (filtering, shielding, grounding), test laboratory coordination, and technical file preparation for CE marking.

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