We offer a highly qualified service that prioritizes meeting deadlines along with the highest product’ quality audit standards, with the aim of bringing solutions and an excellent assistance to our customers
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IVDR: Implementación progresiva y extensión de plazos.
El Reglamento sobre productos sanitarios para diagnóstico in vitro, que se aplicará a partir del 26 de mayo de 2022...
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MDR/IVDR: Commission adopts new standardization request
The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.
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About us
María Mercedes Bertoli
PharmD.
Highly skilled and dedicated Regulatory Affairs Professional with strong capabilities and knowledge acquired over nineteen years of experience working for Pharmaceutical Industries and Consulting Companies, in particular in the fields of Regulatory Affairs, Medical Writing, Quality Control, Quality Assurance, and Systems. Passionate professional able to meet Companies' deadlines and expectations while producing high-quality results for clients.
María Laura Gentile
Biochemestry
More than 15 years of experience working in regulatory affairs of medical products for in vitro use diagnosis (IVD). Part of the Argentine health authority (ANMAT) for more than 10 years. Specialist in the regulations that regulate the market for medical products in Latin America.