Our Services
We provide expert guidance and hands-on execution to help life sciences companies navigate software compliance, regulatory submissions, cybersecurity, and operational efficiency. Our approach focuses on building sustainable frameworks, bridging gaps between teams, and delivering practical solutions that align with both business goals and regulatory expectations.
​Compliance Strategy
& Delivery
We help companies navigate FDA and global software compliance with a practical, structured approach. Whether new to regulations or refining existing processes, we provide clear guidance, implement frameworks, and ensure teams are aligned. Our focus is on knowledge transfer and building long-term capability, ensuring compliance without unnecessary complexity.
Regulatory Submissions & Compliance (510(k), PMA,
De Novo)
We simplify FDA submissions by ensuring your software, risk, and validation documentation meets regulatory expectations. Whether it’s a 510(k), PMA, or
De Novo, we help you organize, prepare, and align with FDA, ISO, and EU MDR requirements. Our experience allows us to streamline the process while identifying potential gaps before submission.
Software Design, Testing & Maintenance
We ensure software is designed, tested, and maintained for both compliance and usability.Our services cover software design, ensuring structures meet both regulatory requirements and user needs; comprehensive testing, including functional, integration, and validation testing; and ongoing maintenance with regular updates, risk-based validation, and continuous compliance monitoring.
Software Development Lifecycle Frameworks & Execution
We help companies build or refine SDLC frameworks that align with FDA, ISO 13485, and IEC 62304. Our focus is on efficiency, risk management, and compliance, ensuring that your development, testing, and release processes are structured, scalable, and well-documented.
Cybersecurity & Risk Management
We integrate cybersecurity into the SDLC to meet FDA and global regulatory expectations.
Our services include risk assessments and threat modeling, security controls and vulnerability management, and regulatory compliance with 21 CFR Part 11 and FDA cybersecurity guidance—ensuring security is built in from the start, not added later.
Laboratory Developed Tests (LDTs) & Operational Optimization
We support LDT development and validation while optimizing lab workflows. Our expertise helps labs improve efficiency, ensure regulatory alignment, and integrate software & automation. Whether preparing for FDA oversight or refining operations, we provide practical, real-world solutions.