Expert Services

Validations QMS Software
& Software as a Medical Device SaMD

Validations QMS Software & Software as a Medical Device SaMD

At AQC, we provide expert consultancy for the validation of Quality Management System (QMS) software and Software as a Medical Device (SaMD), ensuring compliance with ISO 13485:2016, ISO 62304, ISO 14971, MDR 2017/745, and IVDR 2017/746.

Validation of QMS Software (ISO 13485:2016 & 21 CFR Part 11)

What is QMS Software Validation?

Quality Management System (QMS) software validation ensures that software used for regulatory compliance (e.g., document control, complaint handling, CAPA) functions correctly, consistently, and securely.

Regulatory Requirements

  • ISO 13485:2016 – Clause 4.1.6 → Requires validation of software used in QMS
  • 21 CFR Part 11 → Ensures electronic records & signatures are secure and traceable
  • GAMP 5 Guidelines → Risk-based approach to computerized system validation

How We Help

  • Validation planning & risk assessment
  • Software installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
  • Compliance with electronic records & audit trail requirements
  • Documentation & validation report preparation

Validation of Software as a Medical Device (SaMD) – IEC 62304 & MDR

What is SaMD?

Software as a Medical Device (SaMD) refers to standalone software that performs a medical function without being embedded in hardware (e.g., diagnostic apps, AI-based analysis tools).

Regulatory Requirements for SaMD

  • MDR 2017/745 & IVDR 2017/746 → Classifies SaMD based on risk & requires conformity assessment
  • IEC 62304:2006 (Software Lifecycle Processes) → Framework for software development & maintenance
  • ISO 14971:2019 (Risk Management) → Identifies & mitigates software-related risks
  • ISO 27001 (Information Security) → Ensures data protection & cybersecurity compliance

Key SaMD Validation Steps

  1. Software Development Planning (Risk-based approach)
  2. Software Design & Architecture Documentation
  3. Risk Management (ISO 14971 Compliance)
  4. Software Testing (Unit, Integration, System, User Acceptance Testing - UAT)
  5. Cybersecurity & Data Integrity Validation
  6. Performance Evaluation & Clinical Validation
  7. Ongoing Post-Market Surveillance (PMS) & Updates

How We Help

  • SaMD classification & regulatory strategy (EU MDR & IVDR compliance)
  • Software development lifecycle validation (IEC 62304)
  • Cybersecurity risk assessment & penetration testing
  • Technical documentation & Notified Body submission
Alpine Quality Consultants

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