Standards as pathways, not badges
ISO 13485, IEC 62304, ISO 14971 and the Health Canada Class II SaMD pathway — what we are doing and what we do not claim.
Medical technology attracts badge collecting. We take the opposite position: standards are practices we operate by, and we describe them as pathways in progress until an approval is actually issued.
What we operate
Design controls and document control aligned to ISO 13485, a software lifecycle aligned to IEC 62304, and risk management aligned to ISO 14971.
What we do not claim
No certifications are implied, and no Health Canada endorsement exists. NovaPatch Vital remains in development.
Informational only. Nothing here is medical advice, no efficacy or regulatory endorsement is implied, and NovaPatch Vital is in development.