Skip to Content

Manufacture by Doodex › By industry › ERP for Medical devices manufacturing - Odoo + AI by Doodex

The ERP that survives a notified body audit.
ISO 13485, MDR, FDA 21 CFR Part 820 - all in Odoo.

Medical device manufacturers operate under ISO 13485, EU MDR, FDA 21 CFR Part 820 and UDI traceability. Doodex configures Odoo to comply by design, not by exception.

Start your diagnostic - 4 min →

Doodex method

Compliance by design. Audit-ready by default.

First month guaranteed. 100% go-live success rate. 12 years of Odoo expertise.

3 pain points we solve

The 3 problems we hear in every diagnostic call.

Design history file (DHF)

Every device version requires a complete DHF. Odoo PLM module captures design changes, reviews, approvals — auditable end-to-end. No more spreadsheet DHF nightmares.

UDI traceability

EU UDI-DI / UDI-PI must be assigned, printed, tracked from manufacture to patient. Odoo lot/serial tracking handles UDI propagation natively. GUDID/EUDAMED submission automated.

Non-conformity & CAPA

Each NCR / CAPA must be tracked, escalated, closed with full audit trail. Odoo Quality module handles NCR workflows, root cause analysis (5 Whys, Ishikawa) and CAPA closure with linked evidence.

Industry-specific integrations

Your industry tools already speak Odoo. We have the bridge.

Document control & DMS

SOPs, work instructions, training records — Odoo Documents with version control, approval workflows and digital signatures. ISO 13485 clause 4.2 ready.

Training & competency tracking

Mandatory training matrices per role. Odoo HR + Quality track who is qualified for which step. Production blocks unqualified operators automatically.

Calibration & equipment

Equipment calibration schedules, maintenance logs, traceability per device manufactured. Odoo Maintenance configured with calibration-due alerts.

Adverse event reporting

MDR (EU MIR), FDA MDR (Medical Device Reporting) workflows configured in Odoo Helpdesk + Quality. SLA-driven reporting deadlines tracked.

Compliance & regulations

Regulations don't wait. Neither does our compliance layer.

Medical device regulation is the heaviest in manufacturing: ISO 13485 (QMS), EU MDR (Class I-III risk-based), FDA 21 CFR Part 820 (US QSR), Health Canada, TGA Australia. Doodex configures Odoo with regulatory layer that captures every required field at product / batch / device level. Notified body audits become routine, not crisis events.

FAQ

Questions erp for medical devices manufacturing - odoo + ai by doodex buyers actually ask.

Odoo software itself is not "ISO 13485 certified" (that certification applies to organizations, not software). However, Doodex configures Odoo to support full ISO 13485 compliance: document control, training records, NCR/CAPA, design controls, calibration. Many of our customers passed certification audits running Odoo.

Doodex configures Odoo to assign UDI-DI at product creation (linked to GMDN/SNOMED codes) and UDI-PI at batch level (lot, serial, expiry, manufacture date). Labels print with GS1-128 barcodes including UDI. EUDAMED / GUDID submissions automated.

Yes. Odoo PLM (Product Lifecycle Management) captures every design change, review, validation, verification activity. Doodex extends with DHF templates per device class. Auditors get a single, traceable file per device version.

Doodex configures Odoo with audit log on every record (who, what, when, why), electronic signature requirements on critical workflows (release, deviation closure), and access controls per role. Part 11 compliance achieved through configuration, not custom code.

Typical timeline: 12-20 weeks for a single-site Class IIa/IIb manufacturer. Heavier than other industries due to QMS depth. Doodex sequences: QMS document control first (4-6 weeks), production flows (6-8 weeks), regulatory submissions last. First month guaranteed.

Yes — Class III adds clinical trial data integration and post-market surveillance complexity. Doodex configures Odoo with PMS workflows linked to GUDID/EUDAMED, vigilance reporting and risk management (ISO 14971). Classes IIa, IIb, III all supported.

Ready to see what Doodex can do for your factory?

4 minutes. 8 questions. Personalized diagnostic delivered within 48h.

Start my diagnostic →

First month guaranteed · 100% go-live success rate · 12 years of Odoo expertise