Service
Software as a Medical Device (SaMD) Compliance & Development
Ensuring Software as a Medical Device (SaMD) meets global regulatory standards requires a structured approach to software quality planning, risk management, and compliance with IEC 62304. We provide expert guidance and technical assistance to help businesses efficiently develop, validate, and certify SaMD solutions.
Comprehensive SaMD Support
At UpShot, our team specializes in aligning Software as a Medical Device (SaMD) development with international regulatory requirements, ensuring seamless CE marking, FDA approvals and global compliance. We provide end-to-end support to help businesses navigate the complex regulatory landscape, reducing risks and accelerating market entry.
Our SaMD Services
Software Quality Planning
Defining quality objectives and establishing processes to comply with ISO 13485 and IEC 62304 standards.
Software Development Process
Supporting structured SaMD design, coding, and implementation with best practices for software architecture, risk control, and cybersecurity.
Software Risk Management & Compliance
Implementing risk control measures aligned with IEC 62304, ISO 14971, and FDA requirements.
Software Verification & Validation
Ensuring SaMD functions safely and effectively through rigorous testing.
Usability Engineering Integration
Enhancing user experience and patient safety by incorporating human factors engineering as per IEC 62366-1.
