With more than two decades in medical device and software development, we offer turnkey solutions, end-to-end support, or targeted expertise wherever you need it most. Whether you’re a startup shaping your first prototype or an established company scaling production, we reduce risk, accelerate timelines, and ensure compliance at every stage.
What We Offer
Innovation & Development
Concept evaluation, feasibility studies, rapid prototyping, packaging design, and design for manufacturing, delivered under an ISO 13485–compliant QMS. We ensure alignment with IEC 62304 (software), IEC 62366 (usability), IEC 60601 (medical electrical equipment), ISO 14971 (risk management), and ISO 10993 (biological evaluation)
Regulatory & Quality
Design control, risk management (ISO 14971), and submissions (FDA 510(k), CE) under an ISO 13485 QMS.
Product Testing
Verification & validation; usability protocol development and testing; and coordination with accredited third-party labs for cleaning validations, biocompatibility, sterilization validation, packaging validation, and electronics/EMC safety testing.
Manufacturing & Commercialization
Design transfer, process validation, supplier qualification, and market launch support.