IEC 62304 Consulting
Standards-compliant development of medical software – from gap analysis to audit preparation
IEC 62304 – The Standard for Medical Software
IEC 62304 (EN 62304) defines the requirements for the software lifecycle of medical software. Whether standalone software (SaMD), embedded device software or DiGA – without IEC 62304 compliance there is no CE marking.
Our Consulting Services
Gap Analysis
Systematic assessment of your existing processes against IEC 62304 requirements. You receive a detailed report with specific recommendations for action.
Process Implementation
Establishment of an IEC 62304-compliant software development process – from requirements analysis through design and implementation to testing and release.
Documentation
Creation of the software file: software development plan, requirements specification, architecture, test plans, SOUP management and risk management documents.
Audit Preparation
Preparation for audits by Notified Bodies. Mock audits, document review and coaching for your development team.
Training
Practical training on IEC 62304, ISO 14971 (risk management) and IEC 62366 (usability) for your development team.
Relevant Standards & Regulations
- ✓ IEC 62304 – Software lifecycle
- ✓ ISO 14971 – Risk management
- ✓ IEC 62366 – Usability
- ✓ MDR (EU) 2017/745 – Medical Device Regulation
- ✓ DiGAV – Digital Health Applications Regulation
Who Is Our Consulting For?
- ✓ Medical device manufacturers – existing and new software products
- ✓ DiGA startups – fast track to BfArM listing
- ✓ Software companies – entering the medical sector
- ✓ Hospitals – regulating in-house developed software