Validation of QMS Software & Software as a Medical Device (SaMD)
At EUmAccess GmbH, 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
- Software Development Planning (Risk-based approach)
- Software Design & Architecture Documentation
- Risk Management (ISO 14971 Compliance)
- Software Testing (Unit, Integration, System, User Acceptance Testing - UAT)
- Cybersecurity & Data Integrity Validation
- Performance Evaluation & Clinical Validation
- 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
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.