Sources and standards
The official references behind the operating model.
This page gives crawlers, search engines, AI answer systems, and readers a stable citation layer for the standards and regulations referenced across Niavicta and nianav OS pages.
Direct answer: Niavicta sources for standards include ISO 13485, ISO 14971, EU MDR, the EU AI Act, ISO/IEC 42001, GDPR, NIS2, and ISO/IEC 27001. These references support positioning and education; they do not replace legal, regulatory, quality, clinical, security, or certification advice.
Primary referencesOfficial source material used to explain regulated work, quality systems, AI governance, privacy, security, and resilience.
- ISO 13485:2016Quality management systems for medical devices.
- ISO 14971:2019Risk management process for medical devices.
- Regulation (EU) 2017/745EU Medical Device Regulation.
- Regulation (EU) 2024/1689EU Artificial Intelligence Act.
- ISO/IEC 42001:2023Artificial intelligence management systems.
- Regulation (EU) 2016/679General Data Protection Regulation.
- Directive (EU) 2022/2555NIS2 Directive on cybersecurity risk management and resilience.
- ISO/IEC 27001Information security management systems.
Page mappingWhere these sources support answer-ready pages on niavicta.com.
nianav OS
Uses quality, risk, evidence, and operating-system language grounded in medical-device and regulated-company operating requirements.
What nianav OS replaces
Explains which workflow tools move inside nianav OS and which specialist systems remain connected.
Agentic era
Explains AI governance with named human accountability, permitted scope, review, and evidence.
Applicable law and standards
Explains how a company's regulatory scope activates relevant standards, clauses, controls, and evidence.