From concept to cleared device
Design, verification, cleanroom build — controlled end to end
Clinical needs analysis, IP landscape, and feasibility bench work with your team.
Design controls from day one — requirements, risk files, and verification built in parallel.
Human-factors validation, clinical evaluation, and regulatory submission managed in-house.
Scaled production, global logistics, and a 24-hour field-service network for the device's whole life.
Low-noise analog front ends, medical-grade isolated power, and EMC design validated to IEC 60601-1-2 in our on-site pre-compliance chamber. Our boards are designed for a 10-year service life and component sourcing resilience.
ISO 10993 material selection and testing, reprocessing-tolerant polymers, and enclosure chemistry rated for 5,000+ cycles of hospital-grade disinfectants without crazing or discoloration.
IEC 62304 Class C development, native HL7/FHIR integration, and signed over-the-air updates with full rollback. Every release ships with a cybersecurity bill of materials.
Simulated ICU and OR environments on-site, IRB-managed multi-center studies, and post-market clinical follow-up programs that feed directly back into design inputs.
ISO certified
Quality management system, audited and current.
DHF traceability
Every requirement linked to its verification.
In-house design controls, biocompatibility planning, and ISO-classified cleanroom assembly mean your device moves from concept to submission without a handoff that breaks the chain.