Our senior consultants specializing in IEC 62304 help medical software teams establish lean, compliant lifecycle processes without slowing down agile engineering.
- Gap Analysis of Existing Processes: Thorough review of your current software development lifecycle, documentation, configuration control, SOUP handling, and V&V practices.
- Tailored Compliance Roadmap: Clear prioritization of deliverables, roles, and timelines matched to your software safety class (A, B, or C).
- Process Implementation & Risk Integration: Seamless integration of IEC 62304 with ISO 14971 software risk management and modern CI/CD toolchains.
- Audit Readiness & Developer Training: Preparing your team and Technical File for Notified Body or FDA inspections through practical workshops and mock audits.
Email info@glaze-medical.dk or contact us to schedule an informal meeting about your IEC 62304 needs.