Episode 12 – How to create an ISO Standard with Marcelo Antunes
On the Medical Device made Easy Podcast I invited Marcelo Antunes from SQR Consulting to help us understand how the ISO standards we are using are created. Do you know how ISO 13485, ISO 14971 are created? Who is deciding which rules to apply? Are you also angry because some of the requirements doesn’t make sense?
Marcelo Antunes will tell us everything. You’ll know how to create standards and also how YOU can participate in the creation of a Standard which is really important for manufacturers.
We will also discuss about the Elsmar Cove Forum that exist since 1996 and which is a great source of support for the Medical Device industry.
Marcelo Antunes Biography
Marcelo Antunes is a Regulatory affairs strategy consultant at SQR Consulting, São Paulo, Brazil. He has more than 18 years of experience in the medical devices field.
The focus of his work is in the
compliance of the medical device during it’s lifecycle, based on regulations
and standards. He is an expert in Brazilian regulations and CE marking of
medical devices. He also works regulations worldwide.
He’s chairman of the Brazilian mirror to ISO TC 210 (Quality management and general aspects of medical devices) and ISO TC 194 (Biological and clinical evaluation of medical devices). He’s an expert member, appointed by Brazil, of all working groups of ISO TC 210 (quality systems, risk management, software, usability, symbols, and nomenclature) and ISO TC 194, and also some IEC committees, at the international level. He’s a member of RAPS and manager of the RAPS Brazil Network and maintains the Medical Device Expert News blog. He’s also a teacher of medical device development and regulatory affairs at a number of Brazilian universities.
- Marcelo Antunes Linkedin: linkedin.com/in/marceloantunes
- SQR consulting Brazil: http://www.sqrconsulting.com.br/
- The 4-hour workweek (Tim Ferris): https://amzn.to/2EEEdtv
- Medical Device Expert News: http://www.medicaldevice.expert/
- ISO website: https://www.iso.org
- https://www.iso.org/publication/PUB100037.html – My ISO job – What delegates and experts need to know
- https://www.iso.org/directives-and-policies.html – Directives and policies (including ISO/IEC Directives parts 1 and 2)
- https://elsmar.com/elsmarqualityforum/ – Elsmar Cove Forum
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