For oems and machine builders
CE Technical Files that keep pace with your machine variants
Every variant, option and customer change needs its safety evidence updated. MSA links risk assessment, control system calculations and validation into one traceable model, so a design change updates the documents it affects.
Deliverables
- Risk assessment (EN ISO 12100)
- PLr / SIL calculations
- Validation protocols
- ATEX assessment
- IQ/OQ/PQ validation protocols
- Safety Matrix (FAT/SAT)
- CE Technical File
- Test certificates
Situations we solve
Sound familiar?
-
“We’re exporting panels to the EU after Jan 2027.”
Map your machine to Regulation 2023/1230.
See how: We’re exporting panels to the EU after Jan 2027. -
“We modified a machine. Is it a substantial modification?”
Re-assess the change and see what it affects.
See how: We modified a machine. Is it a substantial modification? -
“Our safety PLC is reachable remotely.”
Link IEC 62443 zones to safety functions.
See how: Our safety PLC is reachable remotely. -
“We have a CE audit in three weeks.”
Build the technical file from one model, fast.
See how: We have a CE audit in three weeks.
The challenge
Why the safety package takes so long
Variants multiply documentation
Options and customer-specific changes each need an up-to-date risk assessment and Technical File.
The 2027 transition
Regulation (EU) 2023/1230 applies from 20 January 2027, with updated essential requirements and new rules on digital instructions.
Regulated customers ask for more
Pharmaceutical and food customers expect IQ/OQ protocols and FAT/SAT packs alongside the CE documentation.
With MSA
From engineering inputs to signed-off evidence
- 01
Model
Requirements, drawings and system models define the machine and its limits.
- 02
Assess
Risk assessment, PLr / SIL calculations, guard and access analysis and, where relevant, ATEX assessment.
- 03
Validate
Validation protocols, IQ/OQ/PQ protocols and FAT/SAT test packs generated from the same model.
- 04
Release
CE Technical File and client-ready exports. When the design changes, affected evidence regenerates.
Standards
Standards you’ll work with
How we work with you
Self-Service
You use MSA independently. Best for machine builders, oems, integrators, safety engineers.
Two ways to engage: Safety as SaaS for ongoing projects, or a One-time Safety Sign-off for a single machine or project.
- Full MSA platform
- Safety Intelligence Model
- Generate certification-ready evidence
- 100% offline deployment
- Word, PDF, Excel — client-ready output
Frequently asked questions
Is MSA ready for the EU Machinery Regulation?
MSA is designed to be ready for Regulation (EU) 2023/1230, which applies from 20 January 2027.
Which formats can we export?
Word, PDF and Excel — client-ready output.
See MSA on your own project
Bring a recent machine or process package. We’ll show you how MSA turns the same engineering inputs into certification-ready evidence.