Trust center
Compliance, privacy and clinical confidence.
Access the key information behind NOMICS regulatory compliance, data protection, cybersecurity and clinical affairs.
1. CE — Regulatory & Compliance ISO & MDR
Our Commitment to Quality, Safety & Regulatory Compliance
At Nomics, we are committed to product safety, quality and regulatory compliance. Our products are designed, manufactured and monitored in accordance with Regulation (EU) 2017/745 on medical devices (MDR), within a Quality Management System certified to ISO 13485:2016.
EU MDR Certificate
Compliance with the EU Medical Device Regulation (MDR)
The NS500 Apios platform, developed by Nomics, is a Clinical Decision Support System intended to provide information to qualified healthcare professionals across the sleep-disordered breathing care pathway. It is CE marked as a medical device under the Regulation (EU) 2017/745 (MDR).
ISO 13485 Certification
Quality Management System for Medical Devices
The Nomics Quality Management System is certified to ISO 13485:2016, demonstrating our commitment to consistent quality, effective risk management, and the continuous improvement of processes related to medical devices.
This certification supports our commitment to maintaining a structured Quality Management System aligned with applicable medical device requirements.
Transparency & Documentation
We are committed to transparency and maintaining up-to-date regulatory and quality documentation. For further information regarding our certifications or regulatory compliance, please contact us at quality@nomics.com.
2. GDPR
Information related to personal data protection, privacy practices, data processing and GDPR compliance.
3. Cybersecurity
Our Commitment to Cybersecurity
At NOMICS, we are committed to protecting our solutions and the data entrusted to us. We implement appropriate security measures to safeguard our systems and ensure the confidentiality, integrity and availability of data.
