Event
Baüne accelerates global compliance with ISO 13485 and ISO 27701
Montreal, QC – November 19, 2025
In June 2025, Baüne reached a major regulatory milestone by obtaining its Health Canada Medical Device Establishment License (MDEL). This achievement underscores our commitment to meeting stringent Canadian regulatory requirements and lays the foundation for global compliance and quality assurance paving the way for international certification and trusted healthcare innovation.
Building on this success, Baüne has engaged a specialized advisory group to accelerate the implementation of internationally recognized standards that align with our technology roadmap and reinforce our dedication to quality, regulatory compliance, and data privacy.
Strategic Standards Implementation
Our initiative includes:
- ISO 13485:2016 – Medical Device Quality Management Systems Establishing a robust quality management system to ensure product safety, reliability, and compliance with global regulatory requirements.
- Medical Device Single Audit Program (MDSAP) Enabling a unified audit process that satisfies multiple jurisdictions, including Health Canada, FDA (United States), and other participating authorities, streamlining global market access.
- ISO 27701:2025 – Privacy Information Management Extending our information security framework to include privacy governance, ensuring compliance with international data protection standards and safeguarding sensitive health information.
Our implementation process is underway, and we are targeting certification by the end of Q3 2026. This timeline reflects a structured, realistic approach to compliance, ensuring readiness for future innovation and international deployment.
“Compliance is not just a regulatory requirement it is the cornerstone of trust, safety, and innovation in healthcare across every domain we serve.”
- Aurelien Balondona, Baüne CTO
Impact Across Domains
Securing these certifications will unlock significant advantages for Baüne, among many others, including:
Space & Defense Applications
- Deploy autonomous health systems in extreme environments.
- Ensure interoperability with defense and aerospace health protocols.
Terrestrial Healthcare & High-Performance
- Athletes Deliver compliant solutions for hospitals and clinics.
- Enable predictive care for elite athletes.
About Baüne
Baüne is a Canadian space health technology company advancing autonomous, integrated, and interoperable healthcare systems through its Human Digital Twin (HDT) platform, built on the Predictive, Preventive, Personalized, and Participatory (P4) model. Designed for space and terrestrial domains, Baüne’s technologies deliver real-time, multimodal health intelligence using AI System-Level Autonomy and Health Knowledge Graphs, deployable online or offline.
Baüne is currently validating its autonomous care systems with provincial healthcare institutions in Quebec. The company is transitioning these technologies into a scalable System-as-a-Service (SaaS) model, enabling decentralized, preventive care for anyone, anywhere, even in underserved communities and challenging locations.
Learn more about our compliance journey at: https://baune.io or contact us on our connect form or email startwith@baune.io