Developing Software as a Medical Device (SaMD) requires balancing agile development with strict regulatory requirements. Rook Quality Systems has over a decade of hands-on experience working with software companies to streamline this process, ensuring compliance while maintaining efficiency. 

From regulatory-aligned SDLC support to audit-ready software design file creation and cybersecurity compliance, we help you navigate the complexities of SaMD without disrupting your development workflow.

Our Software As a Medical Device Services

• SaMD Regulatory Guidance
• Validation & Testing Strategies
• Software Release Cycles Support 
• AI/ML Process Establishment
• PCCP Development & Implementation 
• Cybersecurity DHF
• Cybersecurity Compliance 

The Value of RookQS SaMD Support

• Seamless Integration with Agile Development – We help align agile software development with regulatory requirements, ensuring compliance without disrupting sprint cycles.
• Expert Compliance Guidance – We know how much of a headache it can be to keep up with today’s complex regulatory landscape, especially for SaMDs. Our team navigates complex global regulations, including FDA, EU MDR, and ISO 13485:2016, to streamline your SaMD approval process for your desired markets.
• Comprehensive Cybersecurity & Risk Management – We assist in developing cybersecurity documentation, risk assessments, and compliance harmonization to meet evolving regulatory expectations.
• Efficient DHF & SDLC Documentation – From Software Development Life Cycle (SDLC) support to Design History File (DHF) creation, we ensure your documentation is robust, audit-ready, and aligned with industry best practices.