Healthcare & Wellbeing Technology Compliance Specialists
Neural Vibe accelerates market access for SaMD, AIaMD, and Wellbeing Technologies while ensuring compliance with ISO Management Standards and local regulatory requirements across global markets.
We specialize in Medical Device Compliance & ISO Implementation services for healthcare technology companies seeking regulatory approval worldwide.
Our Services
Medical Device Compliance
End-to-end SaMD certification support through the entire compliance lifecycle.
AIaMD Frameworks
Comprehensive AI/ML compliance frameworks for artificial intelligence as medical devices.
Wellbeing Tech Compliance
Regulatory guidance for wellness and digital health technologies.
ISO Management Systems
Implementation of ISO 13485, ISO 14971, ISO 27001, and other quality management standards.
AI Advisory
Strategic AI governance and compliance consulting for healthcare organizations.
Regulatory Affairs
Expert regulatory strategy and submission support across global markets.
Global Markets
We support market access across major healthcare markets including:
- United States (FDA) - 510(k), PMA, De Novo pathways
- European Union (CE Marking) - MDR compliance and notified body support
- United Kingdom (UKCA) - Post-Brexit regulatory pathways
- Canada (Health Canada) - Medical device licensing and MDSAP
- Australia (TGA) - Conformity assessment and inclusion
- Brazil (ANVISA) - Registration and good manufacturing practices
Contact Information
Get in touch with our regulatory experts: