Save time and stay compliant
There are a few months left.
What impact on the compliance of your machines?
The mandatory application of the new European Regulation comes into force in January 2027. Optima AI® Automate all your CE compliance: risk assessments, instruction manuals, technical files.
Countdown — 20 January 2027
Compliance checklist
An all-in-one platform for your CE compliance
Whether you are a machine manufacturer, integrator or user, we will help you to comply with the new European regulations with ease.
EU Declaration of Conformity
Has your "EC Declaration" been updated to "EU Declaration" referencing EU Regulation 2023/1230?
Machine instructions
Is your instruction manual structured according to the requirements of ISO 20607?
ISO 12100 risk assessment complete
Does your risk analysis cover the potential capabilities of the machine, including scenarios involving embedded software?
Embedded cybersecurity requirements
Is the machine documented on its ability to log access, indicate its software configuration and protect its settings?
Compliance with authorities
In the event of an inspection by the labour inspectorate or CPAM, is your file complete and immediately presentable?
30 minutes to see Optima AI® in action. Our team will show you how to transform your CE compliance process with an example from your own business.
Market readiness level
The most frequent errors that we observe.
01
Regulatory ignorance
The majority of manufacturers know that there is a new regulation. Very few are aware of the practical implications for their technical file, their instructions, and their risk analysis.
02
Underestimation of risk analysis
Risk analysis is at the heart of the technical file. It is systematically treated as a formality, even though the regulation significantly strengthens its requirements.
03
Declaration / certification confusion
Many manufacturers confuse the declaration of conformity (self-declaration) regime with the notified body certification regime. These are not the same obligations.
The difference Optima AI®
What design offices do in weeks. We do in hours.
Without Optima AI®
Manually written note from a blank page, 5 to 10 days per machine
ISO 12100 risk assessment subcontracted or incomplete
Difficult document update
Risk of forgetting new cybersecurity requirements
Incomplete technical file in case of inspection
Engineers working on shaping, not design.
With Optima AI®
Machine instructions in a few minutes
ISO 12100 risk analysis generated, structured, immediately usable
Automated update
Regulatory and normative base: Regulation 2023/1230, ISO 20607, ISO 12100
Data privacy guaranteed (sovereign AI hosted in France)
Your engineers are focusing on the design
2027
21 January 2027.
Are you ready?
There are less than 8 months left. Updating your machinery documentation isn't done overnight.
