DME-CE brings products and assembled systems, directive workflows, risk assessments, manuals and a complete CE dossier together in one workspace.
Manage individual products, production lines and other assembled systems in one workspace. The dashboard shows what is complete and what remains open for each product and project. Each product keeps its own CE dossier, while changes and versions remain traceable.
Separate CE dossier for each product
Project dossier for the assembled system and its interactions
Supplier products and their documents remain separate
Clear progress, change and version history
Complete a guided question list so DME-CE can determine which directives apply, which risks need attention and which topics belong in the manual. Those answers then open the checklist, risk assessment and manual. If the answers change later, the affected work is updated.
Identify applicable directives
Feed the checklist, risk assessment and manual
Update later work when answers change
Turn applicable EU requirements into a practical checklist. Mark each item as compliant, non-compliant or not applicable, add remarks and attach evidence so a reviewer can see why.
The question list selects only requirements from applicable directives
Remarks and evidence per requirement
Ready for review before release
Work through hazards, hazardous situations and hazardous events for a product or project. Visualise the risk with a score before the measure and a remaining-risk score afterwards. Apply the three-step method — inherently safer design first, then safeguarding, then information for use — so the effect of each measure is immediately visible.
Hazards, situations and events across the machine life cycle
Visual risk score before and after each measure
Three-step method: design, safeguarding, information for use
Start from a template based on ISO 20607 and your question list answers. Each chapter explains what to include and provides practical examples. Add remaining-risk warnings from the risk assessment to the manual. Work in a consistent layout and preview the PDF as you write, without fixing shifting tables or formatting.
Guidance and examples for every chapter
Remaining-risk warnings from the risk assessment
Consistent layout with an instant PDF preview
Collect the technical file in structured categories — such as drawings, test reports, applied standards and supplier declarations — instead of one mixed folder. Each item stays linked to the product or project.
Structured technical file categories
Drawings, reports and applied standards
Evidence linked to the product or project
Prepare the EU declaration of conformity using the product, manufacturer and compliance information already stored in DME-CE. Then export the complete CE dossier as one organised package for final delivery and archiving.
Prefilled EU declaration of conformity
Export the complete CE dossier
Organised for final delivery and archiving
Teams use DME-CE to manage products and projects, complete a directive question list, work through a requirement checklist, document a risk assessment, write a user manual, collect supporting CE documents, and prepare an EU declaration of conformity in one workspace.
The directive question list is a guided set of questions. The answers help DME-CE determine which directives apply, which potential risks need attention, and which topics should be described in the manual. That then feeds the checklist, risk assessment and manual. If the answers change later, the affected work is updated.
Yes. Authors submit work such as the question list, checklist, risk assessment and manual. A manager or admin reviews it, can add comments, and approve it or send it back. Released documents can be revised later; earlier versions remain available and show who changed what and when.
The risk assessment works through hazards, hazardous situations and hazardous events across the machine life cycle. A visual score shows the risk before the measure and the remaining risk afterwards. Teams apply the three-step method — inherently safer design, then safeguarding, then information for use — so the effect of each measure is immediately visible.
Yes. Each individual product keeps its own CE dossier. A production line or another assembled system is documented as a project. The products within the assembled system retain their own dossiers, while the project dossier describes the overall system and how its parts work together.
Yes. Add a supplier item as a third-party product when its CE documents already exist outside DME-CE. Those files stay with that product, and you can add it to a project so the project dossier stays complete without merging the individual dossiers.
Yes. When the documentation tasks are complete, teams can export the CE dossier as a package, including the declaration of conformity and supporting documents.
Book a demo and walk through the complete DME-CE documentation workflow with your own use case in mind.
