SFB Profile

Marcelo Antunes RAC

With more than 10 years of experience in medical device consulting, Marcelo is the CEO of SQR Consulting, which specializes in areas of expertise such as risk management (ISO 14971), quality systems (ISO 13485, GMP), regulatory systems (CE mark, ANVISA) and testing and standardization (IEC 60601 series). 

Marcelo is also a professor of Medical Device Design and Development at the Biomedical Engineering Department of the Pontificia Universidade Catolica de São Paulo as well as teaching Medical Device Regulatory Affairs at the Instituto Nacional de Telecomunicações. Marcelo has expertise in medical device standards and regulations in diverse aspects of the medical device lifecycle, including quality systems, risk management, product safety, usability, software and adverse event reporting. He is also extremely involved in standardization activities both at a national and international level. Marcelo is the Chairman of the Brazilian mirror groups to ISO TC 210 (Quality Management and general aspects of medical devices) and IEC TC 66 (laboratory equipment). He is also the convenor of several working groups of the Brazilian mirror committes to IEC TC 62 (Medical Electrical Equipment) and ISO TC 215 (Health Informatics). At an international level, Marcelo is the Brazilian-appointed expert to all TC 210 working groups, as well as the IEC TC 62, IEC TC 66 and ISO TC 215 working groups. 

As a compliance engineer at São Paulo’s Institute for Technological Research from 2001 until 2008, Marcelo performed tests on more than 100 medical devices according to the IEC 60601 family and other standards for ANVISA and CE marking approval.