The page you read before you sign.
For distributors in Latin America, Eastern Europe, MENA and Central Asia, compliance is the deal. This is our evidence — open, documented, and on track.
ISO 13485 — certified, audited, live.
Our entire manufacturing and supply chain operates under a certified ISO 13485 quality management system. Certificates and scope documents are available to qualified partners under NDA.
ISO 13485 Quality Management
Certified QMS covering design, manufacture, sterilization support and distribution of Class IIb sensor systems. Annual surveillance audits by accredited Notified Body.
Manufacturing Control
Cleanroom sensor assembly with full lot traceability — from raw adhesive to serialized final device. Every sensor batch passes 100% functional screening before release.
Proven where it matters.
Summary results from our electrical safety and biological evaluation programs. Full test reports are shared with regulatory authorities and qualified distribution partners.
Electrical Safety
IEC 60601-1 family testing: leakage current, biocompatible housing insulation, battery safety and electromagnetic compatibility (IEC 60601-1-2) — passed.
Biological Evaluation
ISO 10993 biocompatibility program: cytotoxicity, sensitization and irritation testing on all skin-contact materials — all pass, including the 14-day adhesive interface.
Clinical Accuracy
Multi-site accuracy studies against laboratory reference across hypo-, eu- and hyperglycemic ranges, diverse skin tones and climates. MARD < 8.3%.
Where we are. Where we're going.
A transparent view of our regulatory milestones — from ISO 13485 certification to global market registrations.
ISO 13485 Certification Certified
Full quality management system accredited covering CGM sensor design and manufacture.
Biocompatibility & Electrical Safety Programs Passed
ISO 10993 biological evaluation and IEC 60601 electrical safety / EMC test programs completed.
Regional Registrations Ongoing
Device registrations advancing across GCC (SFDA, UAE MOHAP), Türkiye (TİTCK), Brazil (ANVISA), Mexico (COFEPRIS) and Eurasian Union (EAEU) markets — sequenced with launch partners.
Closed-Loop Platform Certification Planned
Regulatory pathway for the integrated Verid closed-loop system (CGM + intelligent insulin pump) — building on our certified foundation.
Need the full dossier?
Qualified partners receive complete test reports, certificates and registration documentation under NDA.
Request Documentation