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ANN ARBOR, Mich., U.S. and NEWCASTLE, Co. Limerick, Ireland – NSF Certification Ireland Ltd., a wholly owned subsidiary of global public health organization NSF, has appointed Robyn Meurant to the position of Executive Director, Product Review. NSF Certification Ireland Ltd. is applying for In-Vitro Diagnostic Regulation and Medical Device Regulation Notified Body designation in the European Union (EU).
In her role, Meurant will apply her extensive medical device and public health expertise to the review of both classical devices and in-vitro diagnostic medical devices (IVDs), greatly expanding NSF's capabilities to offer comprehensive certification services to the European medical device market.
“Robyn brings a long history of exceptional work in this innovative industry, adding to our expert talent pool,” said James Pink, Head of Notified Body, at NSF Certification Ireland Ltd. “She will play a pivotal role in our certification services in Europe.”
Meurant brings more than 30 years of experience in the field of IVDs to NSF Certification Ireland Ltd., both in the medical device industry and as a regulator with the Australian Therapeutic Goods Administration (TGA) and with World Health Organization (WHO) Prequalification. Beginning her career in the medical laboratory industry, Meurant established herself as an expert in serology before focusing on public health issues. Following her career with TGA, she moved to WHO in Geneva, serving as a Professional Officer with the Prequalification Team – Diagnostics Assessment (PQDx).
In her position at TGA, Meurant played a major role in developing the new regulatory framework for IVDs, as well as ensuring international harmonization of the program. Other highlights of her tenure with TGA include serving as representative on the National Pathology Accreditation Advisory Council of Australia to develop high standards for medical laboratories as well as to develop national policy for HIV and hepatitis C testing.
As Professional Officer with WHO, she served as the lead technical officer for application evaluation and dossier assessment and as a lead for the guidance and technical specifications development for IVDs in the scope of WHO Prequalification. In addition, she served in roles for ISO standards development and was a source of expert advice on IVDs. While at WHO, she participated in a number of International Medical Device Regulators Forum (IMDRF) working groups, including the “Table of Contents,” “Competence, Training and Conduct Requirements for Regulatory Reviewers,” “Common Data Elements for Medical Device Identification,” and the current draft revision of the Essential Principles document.
Throughout her career, Meurant has worked in various voluntary positions with the Australian Society of Microbiology (ASM), the Royal College of Pathologists of Australasia Quality Assurance Programme and the National Association of Testing Authorities, Australia. Her tenure at ASM includes serving as Virology Chair of the National Scientific Advisory Committee and the National Convener of the Clinical Serology and Molecular Special Interest Group. In addition, she received ASM’s Distinguished Service Award in 2009.
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NSF (nsf.org) is a global, independent organization that writes standards, and tests and certifies products for the health sciences, water, food and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With operations in more than 170 countries, NSF is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
Based in Newcastle, Co. Limerick, Ireland NSF Certification Ireland Ltd. is a wholly owned subsidiary of NSF. NSF Certification Ireland Ltd. is applying for In-Vitro Diagnostic Regulation and Medical Device Regulation Notified Body designation in the European Union (EU).