Evidence & Quality

Evidence & Quality

Built on Evidence. Engineered to Standards.

Medical technology earns trust through transparency. Here is the technical, clinical, and quality foundation behind the AquaGuide™ platform.

Technical & Clinical Articles

Our Published Analyses

Our team regularly publishes technical analyses on the methods behind our products:

Read all insights

Quality & Regulatory Alignment

Engineered to Medical Software Standards

The AquaGuide™ platform is developed under a quality framework aligned with international standards:

  • IEC 62304 — medical device software lifecycle processes, including software safety classification and structured documentation
  • ISO 14971 — risk management applied across the product lifecycle
  • Fail-safe design — safety partitioning, watchdog monitoring, and controlled fallback behavior in critical modules
  • Zero-trust security — role-based access control, AES-256 encryption at rest, TLS-encrypted transmission, and immutable audit logs

Design Principles

How We Think About Safety

  • The surgeon decides. AquaGuide is a decision-support tool; the final clinical decision always remains with the surgeon.
  • Sterility first. Contactless control is not a convenience — it is a safety feature that protects the sterile field.
  • Data stays in the hospital. On-premise architecture with no cloud dependency.
  • Continuous validation. Algorithms are updated continuously as real-world clinical data becomes available — under controlled, documented processes.

Request Detailed Documentation

For hospitals and evaluation teams, we provide detailed technical and quality documentation on request.

Contact Our Team
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