MedQMS Pro is an integrated purpose-built ERP + QMS platform designed specifically for medical device and healthcare equipment manufacturers. It helps organizations implement and maintain ISO 13485–aligned quality systems by unifying Quality, Production, Inventory, Training, Traceability, and Compliance into one digital platform.

The Problem with Manual QMS & Generic ERP Systems

• Excel-based QMS leads to gaps, duplication, and audit stress

• Generic ERP doesn’t support ISO 13485 workflows

• Quality runs separately from production

• Traceability is manual and error-prone

• Audit preparation becomes last-minute firefighting

Why MedQMS Pro?​

Replaces manual registers & Excel tracking

Complete Traceability from Raw Material to Finished Device

Audit-Ready Digital Records

Get real-time visibility for management decisions

Built for regulated manufacturing. Designed for audits. Loved by operations.

Role-based access & user control

Embed quality into production workflows

MedQMS Pro integrates ISO 13485 workflows directly into production and inventory operations.

Our Solutions

Experience real workflows for quality, traceability, production, and compliance.

Quality Management (QMS)

• Incoming & In-Process QC

• CAPA and Change Management

• Non-conformance Management

• QR Code based Complaint Handling

• Supplier Quality Evaluation

• Audit-ready Digital records

Document & Record Control

• SOPs & Controlled Document Management

• Version control & approval

• Obsolete document management

• Controlled access & revision history

• Digital work orders linked to QC

• Batch & serial number tracking

• Material traceability

• Production & dispatch monitoring

Production & Process Control

• Items Master & Multi-level BOMs

• Forward & backward traceability

• Batch & Serial number Tracking

• Goods receipt with QC

Inventory, Procurement & Traceability

Equipment, Calibration & Maintenance

• Equipment Master Records

• Calibration Scheduling & Records

• Preventive Maintenance

• Breakdown Records & History

• Audit-Ready Equipment Logs

Dashboards & Management Review

• Management dashboards

• Quality KPIs & trends

• CAPA & NC status

• Audit findings tracking

• QMS performance reports

Who Should Use MedQMS Pro?

Medical Device Manufacturers

ISO 13485/9001 Certified Organizations

Whether you're a Startup, SME, or an established manufacturer, we tailor our support to meet your specific product, process, and team needs.

Startups preparing for regulatory audits

Organizations moving from Excel/manual QMS

Ready to Digitize Your Quality & Compliance System?

Built for audits. Designed for operations.