Have questions about our services or want to discuss your specific regulatory needs? Our team is here to help.
2F-9, No. 229, Fuxing 2nd Rd., Zhubei City, Hsinchu County 302052, Taiwan (R.O.C.)
Room 435, 4F, Building E, No. 19-13, Sanchong Rd., Nangang District, Taipei City 115601, Taiwan (R.O.C.)
29122 Rancho Viejo Rd., Suite 212 San Juan Capistrano, CA 92675
info@ebmci.net
+886-3-657-6763, +886-3-667-6691
Error: Contact form not found.
End-to-end guidance on FDA 510(k), EU MDR/IVDR, Health Canada, tFDA; tailored pathways for IVDs and combination products.
Assistance with Clinical Study Strategies and Efficient Data Collection for medical device trials.
Build, implement, and certify robust QMS to ISO 13485 and MDSAP standards, plus procedural support for FDA QSR (21 CFR 820).
From software V&V to IEC 62304 cybersecurity documentation, ensuring your device software meets global safety & security requirements.
Leverage our in‑house AI platform to generate automated market research, competitive landscapes, and data‑driven regulatory pathway reports.