Regulatory
A regulatory strategy built for institutional partners.
We treat regulatory milestones as product milestones. Here's where each track stands today.
FDA 510(k)
In progressSubmitted Q2 2026. Predicate devices cited. Class II classification, moderate risk.
ISO 13485
In progressManufacturing QMS certification in audit. Flex facilities (Singapore, Mexico).
HIPAA architecture
CompletePHI encrypted at rest and in transit. Local-first processing. Granular consent.
SOC 2 Type II
In progressSecurity audit underway. Expected completion Q3 2026.
CE Mark
In progressEuropean MDR application submitted Q3 2026. Notified body engaged.
PMDA (Japan)
PlannedRegulatory strategy in development with local partner.
Plumbing code
In progressICC compliance and IAPMO certification for infrastructure components.
Insurance pathway
In progressCPT code application submitted. CMS coverage strategy in development.