Software as a Medical Device (SaMD) Qualification and Classification Assessment
Software as a Medical Device (SaMD) Qualification and Classification Assessment
Software Full Lifecycle Compliance (IEC 62304) Establishment
We provide end-to-end support for establishing IEC 62304 compliant software full lifecycle management systems, including preparation of software requirement specifications, architectural design documents, unit testing, integration testing and system verification documents; establishment of software configuration management, version control and change control processes; as well as software defect management and risk assessment of residual issues.
Cybersecurity & Data Protection Compliance
We provide compliance support including penetration testing, vulnerability scanning and data encryption, and prepare technical documents such as cybersecurity plans and cybersecurity reports.
