FDA compliance is costing you thousands of hours a year.
Class I and II device manufacturers operate under FDA and ISO 13485 requirements that demand traceable, auditable evidence. But when DHR data is scattered across systems, supplier documents are in email, and audit prep is a scramble, compliance becomes a burden that pulls your team away from innovation. The device makers who scale are the ones whose systems generate compliance evidence automatically.
Device History Records are assembled at audit time
DHR completeness is discovered during audit or quality investigation — not maintained in real time. Records are scattered across production logs, email, and shared drives. Traceability is reconstructed after the fact. FDA finds gaps. You scramble to close them.
Supplier qualification documentation is everywhere
Vendor assessments, supplier audits, and compliance certificates are stored in email archives and shared drives. When you need to prove a supplier was qualified or audited, finding the evidence takes days. Regulatory queries are nightmares.
ISO 13485 / 21 CFR audit prep is a years-long project
Pre-audit documentation is assembled manually — design records, risk assessments, validation studies, training records. The quality team spends weeks pulling documents from disparate systems. Auditors always find gaps. You remediate the same issues every cycle.
Device History Records are maintained automatically
When production parameters, lot numbers, and quality data are captured in one system, DHR completeness is automatic. Every production decision is traceable. Traceability investigations take hours, not weeks.
Supplier compliance is documented and visible
When supplier assessments, audit reports, and compliance documents are centralized and version-controlled, you can answer "prove this supplier was qualified" in minutes. Regulatory inquiries become routine.
Audit readiness is a dashboard, not a scramble
When design records, risk assessments, validation documentation, and training records live in the system, audit prep is a report run — not a weeks-long search through email. Auditors see control, not chaos.
You spend less time proving compliance and more time making devices
When your system generates the compliance evidence automatically, your quality team focuses on preventing problems instead of documenting them after the fact.
- →Class I/II medical device manufacturers, $10M–$100M revenue
- →OEMs and contract manufacturers, FDA-registered, 25–150 employees
- →Pre-510(k) or DE Novo cleared device makers
- →Organizations currently managing FDA compliance through manual documentation and spreadsheets
Assess your current regulatory compliance and documentation practices
We review how you currently capture and maintain DHR, supplier qualification documents, design records, and validation documentation. We quantify the cost of dispersed systems and manual traceability.
Design the FDA / ISO 13485 compliant system
We map how Odoo will capture production parameters for automatic DHR generation, maintain centralized supplier records, and store design and validation documentation so everything is version-controlled and auditable.
Implement and validate the system
We configure the system, migrate your documentation, and validate that the system generates compliant records. Your quality team is trained to maintain regulatory control inside the system.
Device History Record Completeness and Traceability
Reviews how DHR data is currently captured and stored. Identifies gaps and quantifies the cost of manual traceability investigations.
Supplier Qualification and Documentation Compliance
Assesses current supplier management practices against FDA/ISO 13485 requirements. Identifies documentation gaps and shows the cost of regulatory exposure.
Audit Readiness and Compliance Documentation Efficiency
Measures the time and effort required for current audit preparation. Identifies documentation that exists but is hard to find. Quantifies the opportunity for automated compliance evidence.
Every engagement starts with an assessment.
Before we recommend anything, we quantify the cost of your current state. The assessment tells you what the problem is worth — and whether solving it makes sense.
Start Your Assessment