My name is Marcelo Antunes and I have more than ten years experience within the medical device industry. Since 2008 I’ve been providing consulting services, through SQR Consulting, in areas such as Risk Management, Quality Systems, Standards and Regulatory Affairs in general.
My clients are medical device manufacturers who need assistance in getting their devices to market in the fastest possible way.
I focus on a Risk based, lifecycle approach to medical device standards, regulations and directives.
I am active within ISO and IEC working groups and I’m an expert member in working groups of TC 210 – Quality systems and general aspects for medical devices, IEC SC 62A and 62D – medical electrical equipment and ISO TC 215 – Health informatics. This participation enables me to have inside quality information on standards such as ISO 13485, ISO 14971, IEC 60601, and also enables me to offer better help to my clients by using correct interpretations of the standards.
I also work with the Brazilian Medical Device Importers Association (ABIMED), helping their members in understanding and implementing the Brazilian regulations set forth by our regulatory body, ANVISA.
I´m deeply involved with RAPS – the Regulatory Affairs Professional Society. I manage their Raps Brazil Network and my knowledge of regulatory systems in general (Brazil, South America, EUA and EU) has enabled me to obtain the RAC GS – Regulatory Affairs Certification – Global Scope.
For more information about myself, plese refer to my Linkedin Profile
For information about the services I offer, please surf this website, in particular the “Services” and “Training” section.