Biomedical Engineers in the United States.
Medical-device design, FDA regulatory, V&V, ISO 13485 QMS, IEC 60601 testing, and clinical software — vetted engineers and firms nationwide.
America's directory for biomedical engineers.
Biomedical engineering sits at the intersection of mechanical, electrical, and software disciplines with biology, materials, and FDA regulatory practice. Device design, risk management, V&V, and clinical software all require specialized cross-disciplinary engineers.
EngineerMint lists biomedical engineers, regulatory consultants, and firms with proven 510(k), De Novo, and PMA submission track records — plus the facility MEP P.E.s who deliver compliant labs and hospital build-outs.
Post a biomedical engineering scope to the marketplace, or run the AI Estimator for a ROM cost on device, regulatory, or facility work.
Real licensed engineers, sourced from official boards
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Frequently asked questions
What does a biomedical engineer do?+
Biomedical engineers design medical devices, diagnostics, implants, and clinical software — combining mechanical, electrical, and software engineering with biology, materials science, and FDA regulatory practice.
Do biomedical engineers need a P.E. license?+
Most product-side biomedical work is unsealed, but facility engineering for hospitals and labs (HVAC, medical gases, electrical) requires sealed MEP designs from P.E.s licensed in the project state.
What FDA pathways do biomedical engineers work in?+
510(k), De Novo, PMA, and HDE pathways, plus IDE for clinical investigations. Most projects also require ISO 13485 QMS, IEC 60601 testing, and IEC 62304 for software in medical devices.
What credentials matter for biomedical engineers?+
ASQ Certified Biomedical Auditor, RAC (Regulatory Affairs Certification), plus deep experience in ISO 13485, ISO 14971 risk management, and applicable IEC standards.
Can I post a biomedical engineering project?+
Yes. Device design, regulatory strategy, V&V, clinical software — post a brief and qualified biomedical engineers will respond.