Health Canada
Class II SaMD pathway under the Medical Devices Regulations (in preparation).
Compliance & Quality
Compliance is our operating culture
NovaMed is pre-certification and says so plainly. What sets us apart is that the quality system, privacy architecture, and ethics pathway are being built before commercialization — so every claim we eventually make is backed by auditable evidence.
Standards & pathways
ISO 13485 (MDSAP)
Quality management system aligned and building toward certification.
IEC 62304 · ISO 14971
Medical-software lifecycle and risk management in engineering practice.
PIPEDA · BC PIPA
Canadian privacy alignment; PIAs and security assessments for pilots.
Research ethics
Clinic pilots proceed only under Research Ethics Board approval with physician oversight.
Status as of 2026. Certifications and licences listed are pathways in progress, not issued approvals.
