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Medical Devices Audit & Compliance

Navigate FDA, ISO 13485, and MDR requirements with confidence. Ensure complete traceability, automated CAPA workflows, and audit-ready documentation for the most stringent regulatory environments.
FDA Compliant
ISO 13485
MDR Ready
21 CFR Part 820

Specialized Audit Capabilities

Comprehensive audit framework designed specifically for medical device manufacturing and quality assurance

Design Control Audits

Verify design and development processes comply with FDA requirements and ISO 13485 standards, ensuring complete design history files and verification/validation documentation.

Document

Process Validation Audits

Assess installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) to ensure manufacturing processes produce consistent, compliant results.

Supplier & Vendor Audits

Evaluate critical suppliers and contract manufacturers to ensure they meet quality standards and regulatory requirements for components and materials.

Quality Control Audits

Quality System Audits

Conduct comprehensive QMS assessments covering all aspects of ISO 13485 and FDA QSR requirements with complete traceability and documentation.

Post-Market Surveillance Audits

Monitor complaint handling, adverse event reporting, and post-market vigilance activities to ensure ongoing compliance and patient safety.

Project Milestone Audits

Regulatory Compliance Audits

Prepare for and maintain readiness for FDA inspections, Notified Body audits, and other regulatory assessments with comprehensive audit trails.

Regulatory-Grade Management Solutions

Purpose-built tools to meet the unique demands of medical device compliance
Centralized Document Control

Document Control

21 CFR Part 11 compliant document management with version control, electronic signatures, and complete audit trails for all quality documentation.
Issue Resolution Tracking

CAPA Automation

Automated corrective and preventive action workflows with root cause analysis, effectiveness checks, and regulatory-compliant closure documentation.
Proactive Risk Monitoring

Risk Management

ISO 14971 compliant risk management throughout the product lifecycle, from design through post-market surveillance with full traceability.
Permit & Certification Manager

Traceability Matrix

Complete device history records (DHR) and design history files (DHF) with automated traceability from requirements through production.
Real-Time Project Dashboards

Change Control

Structured change management process ensuring all modifications are evaluated, approved, and documented according to regulatory requirements.
Mobile Field Capabilities

Deviation Management

Track and investigate non-conformances with automatic escalation, impact assessment, and linkage to CAPA when required.

Built for Medical Device Regulations

Our platform ensures compliance with the most stringent regulatory frameworks in the medical device industry
FDA 21 CFR Part 820
ISO 13485:2016
EU MDR 2017/745
ISO 14971 Risk Management
21 CFR Part 11
MDSAP

Ready to Achieve Regulatory Excellence?

Streamline compliance, reduce audit preparation time, and maintain continuous regulatory readiness
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