COMPLIANCE ASSURANCE

In addition to shaping the technical and product vision, we support you with comprehensive compliance assurance across all major medical and HealthTech regulatory frameworks. Our team helps you understand, prepare for, and align your solution with the standards and processes required for safe, reliable, and audit-ready medical software and connected devices.

We guide you through the regulatory landscape relevant to your product, including:

• ISO 13485 – Medical Device Quality Management Systems
  Ensuring your development and organizational processes follow the strict requirements for medical device design, risk management, documentation, and continuous improvement.

• IEC 62304 – Medical Software Lifecycle Processes
  Helping you structure, document, and validate your software development workflow to meet the expectations for safety-critical medical applications.

• Software Quality Assurance & Risk Management
  Implementing best practices for verification and validation (V&V), cybersecurity by design, usability engineering, and robust testing strategies to meet both regulatory requirements and real-world reliability.

Our approach ensures that compliance is not treated as a late-stage checkbox, but as an integral part of the innovation process. We help you build a solution that is regulator-ready, audit-friendly, and aligned with patient safety from the very beginning.