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510(k) Clearance in Record Time

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by EBMCI

Achieved FDA 510(k) clearance in 4 months vs. industry average of 9 months for an innovative diagnostic device.

Next: EU MDR Transition Success→

Regulatory Strategy & Registrations

End-to-end guidance on FDA 510(k), EU MDR/IVDR, Health Canada, tFDA; tailored pathways for IVDs and combination products.

Clinical Study Services

Assistance with Clinical Study Strategies and Efficient Data Collection for medical device trials.

Quality Systems & Auditing

Build, implement, and certify robust QMS to ISO 13485 and MDSAP standards, plus procedural support for FDA QSR (21 CFR 820).

Software & Cybersecurity Services

From software V&V to IEC 62304 cybersecurity documentation, ensuring your device software meets global safety & security requirements.

MDVICEFUSION AI‑Driven Total Solution Platform

Leverage our in‑house AI platform to generate automated market research, competitive landscapes, and data‑driven regulatory pathway reports.