Linked product records
Attach CE tracking to products already in your compliance master data.
CE Marking Software
CE Marking Software for Self-Declaration Conformity
Identify the applicable directives, assemble your technical file, and produce a signed Declaration of Conformity — linked to the same product records you already manage.
Market-access conformity, without a separate spreadsheet
CE marking self-declaration means proving — and keeping proof of — conformity to the right directives for every product you place on the market. ISOXPERT Compliance360 links CE marking directly to your existing Products & Services records, so you’re not duplicating data, and closes the loop with a 21 CFR Part 11 electronic signature on the Declaration of Conformity.
Key capabilities
From product to signed declaration, in one connected workflow.
AI category identification
AI helps identify the right product category and applicable directives.
Conformity route tracking
Track status: compliant, in progress, pending or non-compliant.
Technical file assembly
Bring together the evidence your Declaration of Conformity depends on.
Declaration of Conformity
Generate the declaration from your tracked directives and evidence.
21 CFR Part 11 e-signature
Sign the declaration with a compliant electronic signature and audit trail.
How it works
- Link a product — from your existing Products & Services records, or add a new one.
- Identify the directives — AI helps identify the product category and applicable directives.
- Track the conformity route — module A self-declaration status per product.
- Assemble the technical file — the evidence behind the declaration.
- Sign the declaration — a 21 CFR Part 11 electronic signature closes the record.
Standards & frameworks
CE marking21 CFR Part 11ISO 9001REACHRoHSZDHCGDPR / PDPL
Why ISOXPERT Compliance360
- No duplicate data — CE marking links to the product records you already maintain.
- AI-assisted classification — a starting point for the applicable directives, not a blank form.
- One conformity dashboard — compliant, in-progress, pending and non-compliant products at a glance.
- Compliant sign-off — a 21 CFR Part 11 electronic signature on every Declaration of Conformity.
Frequently asked questions
Is CE marking included in every plan?
CE Marking is a module enabled per organization in Settings — check with your account owner if you don’t see it in your workspace.
Can AI tell me which directives apply?
AI helps identify the likely product category and applicable directives as a starting point; you confirm the correct conformity route for your product.
Does it produce the Declaration of Conformity document?
Yes — the Declaration of Conformity is generated from your tracked directives and technical file, ready to sign.
How is the declaration signed?
With a 21 CFR Part 11 electronic signature: you re-authenticate and state the reason for signing, and the signature is bound to the record and audit trail.
See it for yourself
One Platform. Unlimited Possibilities. Total Compliance.