Verification & Validation (V&V)
Ensure rapid market entry and global compliance with our expert V&V services, guaranteeing that all devices meet the highest international performance and safety standards.
- Full-scope Design & Development and Verification & Validation adherence to critical regulatory specifications such as: ANSI S3.6, IEC 60645 Series, ISO 8253-1 & 8253-3
- Device & Measurement V&V: Comprehensive validation for diagnostic hearing and balance devices, measurements, and target verification protocols.
- Hearing-Aid Target Verification: Rigorous V&V against industry-standard prescriptive fitting formulae: NAL-NL2, NAL-NL3, and DSL v5.0 to ensure clinical efficacy and provider confidence. - Interoperability & Data Integrity:
- Industry Protocol Compliance: Dedicated expertise in IMC Protocols, HIMSA Documentation, and ensuring full NOAH Conformance for seamless integration into clinical workflows.
- V&V of Custom Fitting Products and Proprietary Algorithms.
Next-Generation AI & Low-Latency Hearing Solutions
Future-proof your hearing instrument portfolio with cutting-edge, processor-optimized algorithms.
- State of the Art: Design and development of next-generation, low-latency, AI-enabled hearing-aids.
- Real-Time Optimization: Optimization of digital signal processing (DSP) using AI-based algorithms for real-time sound enhancement, intelligent content-type classification (e.g., speech-in-noise, music, silence).
Seamless Software & Data Ecosystem Integration
We develop the core software infrastructure to enhance clinical workflow efficiency and data security.
- Integrated Patient Management Software (PMS): Development and seamless integration of your proprietary audiology software with clinic-wide Patient Management Systems (PMS), fully conforming to NOAH standards for unified data management.
- Custom Reporting & Documentation: Creation and customization of detailed, compliant Diagnostic Reports through an integrated, flexible report management system, providing audiology professionals with actionable, clean data.
Get expert guidance on hardware, software, AI, and compliance ensuring your devices meet global standards.