The page you read before you sign.
For partners 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.
- QMS covering design, manufacture, sterilization support and distribution of Class IIb sensor systems
- Annual surveillance audits by an accredited Notified Body
- Certificate on file, design history file, risk management to ISO 14971
- Cleanroom sensor assembly with full lot traceability, raw adhesive to serialised device
- 100% functional screening before every batch release
Proven where it matters
Summary results from our electrical safety and biological evaluation programmes. Full test reports are shared with regulatory authorities and qualified partners.
- IEC 60601-1 family — leakage current, housing insulation, battery safety, EMC (60601-1-2): passed
- ISO 10993 — cytotoxicity, sensitisation, irritation on all skin-contact materials, including the 15-day adhesive interface: passed
- Multi-site accuracy — 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
Full quality management system accredited, covering CGM sensor design and manufacture.
Biocompatibility & electrical safety
ISO 10993 biological evaluation and IEC 60601 electrical safety / EMC programmes completed.
Regional registrations
Advancing across GCC (SFDA, UAE MOHAP), Türkiye (TÏTCK), Brazil (ANVISA), Mexico (COFEPRIS) and the Eurasian Union (EAEU), sequenced with launch partners.
Closed-loop certification
Regulatory pathway for the integrated Verid closed-loop system (CGM + intelligent insulin pump), building on our certified foundation.