About AVRA
A U.S.-based, founder-led medical-device consulting practice connecting engineering evidence, regulatory requirements, and real clinical conditions of use.
Meet the Founder
Abdon Marques Cunha
Clinical & Electrical Engineer
Founder & Principal Consultant
Abdon brings 25+ years of experience across clinical engineering, medical-device operations, technical leadership, international supplier evaluation, and regulatory compliance. His background spans field service, hospital-based clinical engineering leadership, and technical and regulatory management in the medical-device sector.
His work is grounded in how devices are actually deployed, maintained, and used — helping clients align regulatory documentation with technical evidence and real clinical conditions.
Experience that travels across borders
AVRA currently manages a 44-registration ANVISA portfolio. Abdon has executed more than 38 registrations, serves as formally designated technical authority for 38 registered devices, and has led technical-quality assessments in more than 20 manufacturing facilities in China directly in Mandarin. His cross-border work also includes manufacturers in Taiwan, Europe, and Pakistan.
Credentials
- CREA professional engineering registration — Brazil
- Formally designated Technical Responsible before ANVISA for 38 registered devices
- FDA medical-device regulatory training — 44 hours, July 2026
- ISO 13485 Lead Assessor — in progress
- ISO 9001:2015 Lead Auditor — TÜV Rheinland
- Graduate Certificate in Clinical Engineering — UNICAMP
- Graduate Certificate in Occupational Safety Engineering — UniEVANGÉLICA
- Postgraduate lecturer in Clinical Engineering — Instituto Navigare, since 2019
U.S.-focused · Clinically grounded · Internationally informed