Cleared, marked and audit-ready
The submissions and certifications your procurement team checks first
STANDARDS WE BUILD TO
CURRENT CERTIFICATION STATUS
ISO 14971 risk files opened at concept stage and maintained as living documents through end of life.
Requirements, traceability matrices, and design reviews gated in our eQMS — nothing advances without sign-off.
On-site EMC, electrical safety, and simulated-use labs; independent third-party confirmation for every clearance.
Fleet telemetry, complaint trending, and PMCF studies feed a closed loop back into design inputs.
Yes. Our ISO 13485, MDSAP, and CE certificates, plus a signed quality agreement template, are available as a single documentation package — request it through the contact page and our regulatory team responds within two business days.
FDA cleared
Regulatory pathway experience across product lines.
CE marked
Compliant with EU Medical Device Regulation.
FDA 510(k), CE MDR technical files, biocompatibility per ISO 10993 and full design verification — the documentation is ready before your auditors ask.
Audit-ready, always
Certificates, quality agreement template, MDS2 forms, and SBOMs — everything your vendor qualification needs, in one delivery.