ISO 13485 Compliance Software

ISO 13485:2016 Medical Devices

Quality management system requirements for medical device design, development, production, and servicing.

How ExceleorQMS Supports ISO 13485

Purpose-built tools to help you achieve and maintain ISO 13485 compliance efficiently.

Gap Analysis

Clause-by-clause assessment with 0-4 scoring system

Document Templates

Pre-built document frameworks aligned to requirements

Audit Scheduling

Automated audit calendar with reminders

Compliance Dashboard

Real-time compliance scoring and trend tracking

CAPA Management

Corrective and preventive action tracking

Risk Register

Risk assessment matrix with mitigation plans

Why Choose ExceleorQMS for ISO 13485?

Reduce certification preparation time by up to 60%
Eliminate manual spreadsheet tracking
Ensure nothing falls through the cracks
Generate audit-ready reports instantly
Track multiple standards simultaneously
Collaborate across departments seamlessly

Built by an Auditor

ExceleorQMS was designed by a certified 3rd party auditor who has conducted ISO 13485 audits across multiple industries.

No credit card required

Commonly Paired With ISO 13485

Organizations pursuing ISO 13485 often implement these related standards. ExceleorQMS supports cross-standard mapping to eliminate duplicate effort.

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Start Your ISO 13485 Compliance Journey

Join manufacturers who use ExceleorQMS to streamline their ISO 13485 compliance management.