Huasi Biomedical is my private firm to provide exclusively support to Regulators, Notified, Certification, and Accreditation Bodies.
Ramiro Fabian Casas
Founder & CEO at Huasi Biomedical
Senior Regulatory and Quality Officer on Medical Devices Regulations including:
EU MDR 2017/745
US FDA 21 CFR Parts 801/803/ 806/807, 820, 830/831
ISO 13485:2016 under MDSAP, EN ISO 13485:2016
INMETRO Ordinance 384-2020
Latin American Regulations (COFEPRIS, ANVISA, others)
Contract Lead Auditor & Technical Expert/Reviewer for Regulators and Notified/Certification Bodies specialized on biomedical technology including ventilation, imaging, monitoring, cardiology and non-active implantable devices.
Contract MD Codes expertise - different levels of seniority according to formal qualification records:
Active Non-Implantable Medical Devices:
MDA 0202 imaging non-ionizing radiation
MDA 0203 vital physiological parameters
MDA 0204 other monitoring /diagnosis
MDA 0302 non-ionizing radiation
MDA 0305 stimulation
MDA 0306 extracorporal
MDA 0307 respiratory
MDA 0308 wound/skin care
MDA 0309 ophthalmologic
MDA 0310 ENT
MDA 0312 surgical
MDA 0313 patient positioning & transport
rehabilitation and active prostheses
MDA 0315 software
MDA 0317 disinf & sterilization
MDA 0318 other active
Non-active Implantable Devices:
MDN 1101 cardiovascular
MDN 1102 orthopedics & functional
MDN 1104 soft tissue
Non-active Non-implantable devices:
MDN 1201 anesthesia, emergency and intensive care
MDN 1202 injection, infusion, transfusion and dialysis
MDN 1203 guide catheters, balloon catheters, others
MDN 1204 bandages clamps
MDN 1205 orthopedics and rehabilitation
MDN 1206 ophthalmologic
MDN 1208 instruments
MDN 1211 disinfection, cleaning, rinsing
MDS 1005 sterile EtO RAD Steam
MDS 1006 reusable surg inst
MDS 1009 SW
MDS 1010 measuring
MDS 1011 packs
MDS 1012 non-medical purposes.
