SALESFORCE-NATIVE MEDICAL DEVICE ERP
ERP for medical device manufacturers. Built for auditable operations.
Quality, traceability, and production in one connected record.
When an auditor asks for a lot history, your team needs a complete answer. Axolt connects device traceability, quality holds, production, and inventory directly inside Salesforce.
Salesforce-native
Lot & serial traceability
Connected quality
Device traceability flow
● Connected workflow
Material receipt & inspection
Check incoming components and supplier lots against approved vendor records.
Inspect
Lot / UDI assignment
Connect raw materials, work in progress, and finished device genealogy.
Trace
Production & quality hold
Keep affected lots under control when an inspection fails.
Hold
DHR/DMR release & shipment
Build device history from the same records used to run production.
Release
Traceability
UDI & lot genealogy
Quality
Holds tied to production
CAPA
Non-conformance management
Documentation
DHR/DMR-ready records
One connected operational record. Quality, traceability, production, and inventory work together inside Salesforce.
THE COMPLIANCE GAP
Why audit requests become fire drills
Medical device manufacturers need a connected record across quality, traceability, production, and inventory.
WHO THIS IS BUILT FOR
Device manufacturers on Salesforce
Medical device manufacturers and contract manufacturers running or evaluating Salesforce.
Teams certified to ISO 13485 or working toward certification.
Operations managing UDI requirements across quality, inventory, and production.
SIGNS YOU’VE OUTGROWN YOUR SYSTEMS
Disconnected records slow you down
Lot histories take too long to compile because records live in several systems.
Manual quality holds create a risk of affected lots being shipped.
DHR/DMR preparation and CAPA investigations depend on spreadsheets and cross-checks.
Scaling toward a new regulatory submission? Connect your operational records before disconnected processes become harder to manage.
BUILT FOR REGULATED DEVICE MANUFACTURING
Everything medical device ERP needs
Connect the controls and records your quality and operations teams rely on every day.
UDI and lot/serial traceability
Follow genealogy from raw material through finished device and shipment, with records available in real time.
Quality holds tied to production
Connect failed inspections to the affected lot and shipping controls, so teams can act on the same quality status.
DHR/DMR-ready documentation
Build device history and master record documentation from the data used to run production.
CAPA and non-conformance
Track corrective and preventive actions against the specific lot, supplier, and process step involved.
Supplier quality
Connect incoming inspections and supplier scorecards to the components supplied into your devices.
WHY THIS MATTERS ON SALESFORCE
Bring the whole lot history into view
When an audit or field issue raises a question, your team needs connected records and a clear trail of what changed and why.
One Salesforce record
Quality, inventory, and production data live in the same Salesforce org, giving teams a shared operational view.
Faster lot investigations
Find the production, supplier, and inventory records behind a lot without cross-referencing multiple applications.
Multi-site visibility
Maintain traceability by site and roll up inventory and production visibility across your business.
COMMON QUESTIONS
What device manufacturers ask before switching
Discuss your quality processes, validation needs, and existing systems with the Axolt team.
Is Axolt validated for FDA 21 CFR Part 11?
Confirm the current validation status and supporting documentation directly with Axolt before relying on it for a regulatory submission.
Does this replace our existing QMS?
Axolt connects quality processes, holds, CAPA, and non-conformance to live production and inventory data. Whether it replaces or works alongside your QMS depends on your current scope.
How does this handle multi-site manufacturing?
Axolt supports multi-location inventory and production, with traceability maintained per site and rolled up for enterprise-level visibility.
SEE CONNECTED DEVICE MANUFACTURING
Ready for auditable device manufacturing?
See how Axolt connects quality holds, traceability, and production records inside Salesforce. Bring your current workflow and audit requirements to the conversation.