by Waltteri Sorvisto | Apr 29, 2026 | Product & Compliance
Medical device software is often discussed primarily as a development challenge. The focus tends to be on functionality, performance, architecture, and how the final product will behave in use. All of that matters. But in regulated environments, software development...
by adminReaktio | Apr 28, 2026 | Product & Compliance
Our Medical Device Software Development Services Include Software as a Medical Device (SaMD) Development We design and develop standalone medical device software that performs clinical functions such as data analysis, interpretation, and diagnostic support. Our...
by adminReaktio | Apr 28, 2026 | Product & Compliance
Our Cyber Resilience Act (CRA) Services Include CRA Readiness Assessment We evaluate your product, software, and development processes against CRA cybersecurity requirements. This includes identifying gaps in security design, documentation, and lifecycle management....
by adminReaktio | Apr 28, 2026 | Product & Compliance
Our AI Act Services Include AI System Classification and Risk Assessment We assess your AI system under the AI Act framework, including classification as a high-risk AI system, which applies to most AI-enabled medical devices. AI Compliance Strategy and Gap Analysis...
