Marcelo Antunes

Current

Regulatory affairs strategy consultant at SQR Consulting
Forum moderator at Elsmar Cove
Chairman - ABNT CB 26 - CE 26:150.01 - Brazilian ISO TC 210 mirror at Brazilian Standards Association - ABNT

see less...

Past

Regulatory strategy consultant at SQR Consulting
User at Elsmar Cove
Secretary - CB 26 study group at Brazilian Standards Association - ABNT

Researcher / Conformity Engineer at Instituto de Pesquisas Tecnológicas - IPT
Consultant at IPT Institute for Technological Research

see less...

2 more...

Education

Universidade Estadual de Campinas
Universidade Estadual de Campinas
Faculdade de tecnologia de Sorocaba - FATEC

see less...

Recommended

5 people have recommended Marcelo

Connections

163 connections

Industry

Medical Devices

Websites

Marcelo Antunes’s Summary

I have more than 9 years of experience in medical devices consulting. My main areas of expertise are risk management (ISO 14971), quality systems (ISO 13485, gmp, etc.), regulatory systems (CE Mark, ANVISA etc.), testing and standardization (IEC 60601 series, etc.) in general.

SQR Consulting is introducing a new, high-quality, life-cycle integrated solutions vision to the medical device regulatory consulting business in Brazil. We focus not only in compliance, but on a regulatory strategy that uses regulatory compliance to fulfill the business needs in a structured way. As risk management in the product life-cycle is the base for regulatory requirements, we focus on a risk management, life-cycle based regulatory strategy.

--

A SQR Consulting está introduzindo uma nova visão de soluções integradas, baseadas no ciclo de vida dos produtos, para a área de assuntos regulatórios de produtos para a saúde no Brasil. Focamos não apenas em conformidade às regulações e normas, mas sim em uma estratégia regulatória que utiliza a conformidade regulatória para cumprir os objetivos do negócio de uma forma estruturada, agregando valor aos produtos e diminuindo custos para a empresa.

Nossa estratégia regulatória é baseada no gerenciamento de riscos durante o ciclo de vida dos produtos, pois essa é a base para os requisitos regulatórioas na maioria dos mercados.

A SQR Consulting oferece soluções principalmente nas áreas de gerenciamento de riscos (ABNT NBR ISO 14971), sistemas da qualidade (ABNT NBR ISO 13485, BPF, etc.), sistemas regulatórios (Marcação CE,registro Anvisa, ANVISA etc.), ensaios e normalização (Série ABNT NBR IEC 60601, etc.). Informações mais detalhadas podem ser encontradas no seguinte link, em nosso website:

http://www.sqrconsulting.com.br/solucoes/solucoes-sqr/

Fornecemos diversos treinamentos, uma uma lista de treinamentos oferecidos pode ser vista no seguinte link:

http://www.sqrconsulting.com.br/treinamento/treinamento/

Marcelo Antunes’s Specialties:

Medical devices regulatory affairs, medical device safety, medical device risk management, medical device standards, equipamentos eletromédicos, médicos, produtos para a saúde, gerenciamento de riscos, normas, MDD, ANVISA, FDA, quality systems, ISO 13485, ISO 9001, GMP, QSR, 21CFR Part 820, RDC 59, risk management, ISO 14971, usability, IEC 62366, medical device software, IEC 62304, medical electrical equipment, IEC 60601

Marcelo Antunes’s Experience

Regulatory affairs strategy consultant

SQR Consulting

(Privately Held; Medical Devices industry)

November 2009 — Present (2 months)

Please see summary above.
Forum moderator

Elsmar Cove

(Internet industry)

October 2009 — Present (3 months)

Elsmar cove is a forum for quality professionals to gain knowledge and to share knowledge which is active since 1996.

I help moderate the forums on ISO and IEC Medical Device Related Standards:

- ISO 13485 - Medical Devices - Quality Management Systems
- ISO 14971 - Medical Device Risk and Hazard Control
- IEC 60601 - Medical Electrical Products Standards
- IEC 62304 - Medical Device Software Life Cycle Processes
- IEC 62366 - Medical Device Usability Engineering
Chairman - ABNT CB 26 - CE 26:150.01 - Brazilian ISO TC 210 mirror

Brazilian Standards Association - ABNT

(Medical Devices industry)

February 2009 — Present (11 months)

Chairman to study group CE 26:150.01 of the Brazilian National Committe of ISO on Medical Devices, CB-26, mirror of ISO TC 210 - Quality management and corresponding general aspects for medical devices
Regulatory strategy consultant

SQR Consulting

(Privately Held; Medical Devices industry)

June 2007 — October 2009 (2 years 5 months)

Regulatory strategy consultant
User

Elsmar Cove

(Professional Training & Coaching industry)

March 2006 — October 2009 (3 years 8 months)

Elsmar cove is a forum for quality professionals to gain knowledge and to share knowledge
Secretary - CB 26 study group

Brazilian Standards Association - ABNT

(Medical Devices industry)

March 2003 — July 2009 (6 years 5 months)

Secretary to study group of the Brazilian National Committe of the IEC on Medical Electrical Equipment, CB-26, mirror of IEC SC 62A
Researcher / Conformity Engineer

Instituto de Pesquisas Tecnológicas - IPT

(Medical Devices industry)

March 2001 — September 2008 (7 years 7 months)
Consultant

IPT Institute for Technological Research

(Medical Devices industry)

2001 — 2008 (7 years )

Marcelo Antunes’s Education

Universidade Estadual de Campinas

MSC , Biomedical Engineering , 2005 — 2009
Universidade Estadual de Campinas

Specialization , Clinical Engineering , 2003 — 2004
Faculdade de tecnologia de Sorocaba - FATEC

BS , Tecnologia em saúde - Medical devices , 1995 — 2001

Additional Information

Marcelo Antunes’s Websites:

Marcelo Antunes’s Interests:

Biomedical engineering, medical devices risk management, medical device standards, medical devices regulation and quality assurance, IEC 60601, ISO 13485, ISO 14971