Expected field
Place and date of declaration
Exact place and date supplied.
Free editable Word draft · No signup
Free Medical Device Declaration of Conformity Draft Builder
Create an editable preliminary medical device Declaration of Conformity draft from supplied manufacturer, product, UDI, classification, legislation, standards, certificate, and signatory facts.
Paste facts in any format12 expected JSON fieldsEditable branded DOCXUnsupported facts stay blank
Paste the facts for this document
Formatting does not matter. Pi maps reliable facts into this document’s fixed JSON; deterministic code writes the branded editable Word file.
No signature, seal, notarization, legalization, or submission is applied.0 / 50,000
Document-specific contract
Facts this declaration of conformity draft expects
Each field has its own description in the agent prompt and output schema. A key is always present in the JSON, but its value is null when the pasted material does not support it.
Expected field
Manufacturer legal name and address
Exact declaring manufacturer.
When applicable
Authorized representative identity
Representative and supplied registration identifier when applicable.
Expected field
Product and model scope
Exact product names, models, variants, and accessories.
When applicable
Basic UDI-DI or identifier
Exact identifier only when supplied.
Expected field
Intended purpose
Preserve the supplied intended-purpose meaning.
Expected field
Classification and rule
User-supplied class and classification rule only.
Expected field
Applicable legislation
Only regulations or directives explicitly claimed by the user.
When applicable
Conformity assessment procedure
Only the supplied conformity-assessment route.
When applicable
Notified body and certificate
Supplied notified-body identity, number, certificate, scope, and validity.
When applicable
Standards and common specifications
Exact supplied designations and editions; do not add candidate standards.
Expected field
Authorized signatory name and title
Name and capacity only; no signature is applied.
Continue the regulatory workflow
Build a product master
Structure repeated company, product, model, approval, certificate, and evidence facts first.
Fill an official form
Use current stored ANVISA and COFEPRIS source artifacts with form-specific JSON.
Map dossier gaps
Turn an evidence index into a source-backed missing-attachment worklist.
Preflight the package
Check repeated facts, files, signatures, portal mapping, and release blockers.
Other regulatory document builders
Regulatory document builder FAQ
Does the AI write directly into an uncontrolled Word file?
No. Pi must first return the complete document-specific JSON contract. Deterministic code validates that object and writes the editable DOCX.
What happens when a required fact is not in my paste?
The field stays blank and appears in the review list. The workflow is instructed not to guess names, identifiers, dates, powers, classifications, standards, certificates, or authority language.
Does the tool sign, notarize, legalize, certify, or submit the document?
No. The output is an editable preliminary draft. Execution, acceptance, local wording, signatures, notarization, apostille, legalization, translation, and submission remain human responsibilities.
Can I edit the generated file?
Yes. The result is a native DOCX draft intended for review and editing in Microsoft Word or another compatible editor.