Keeping up with the evolving MDR and IVDR regulations can challenge medical device manufacturers. Although the EU Commission has adopted a proposal to give more time to medical device manufacturers, now is the best time to ensure you have a strong understanding of the new and changed translation regulations for both MDR and IVDR set to be implemented progressively between by 2025 and 2028.
To ensure there is no shortage of your life-saving medical products in the EU, download our pre-recorded webinar with MDR and IVDR expert Carlos Galamba, Co-Founder of MDx CRO and Vice President of IVD Intelligence and Innovation at RQM+ and Anna Eisenberg, Director of Life Science Business Development of Morningside, a Questel Company where they will cover:
For more information about Morningside A Questel Company’s language solutions for medical device companies, click here.
About our Speakers:
Carlos Galamba is a seasoned professional in the diagnostics industry with a wealth of experience in both consultancy and regulatory roles. He is the co-founder of MDx CRO and Vice President for Diagnostics at RQM+, one of the world’s largest consultancies fully dedicated to Medtech. In this role, he was responsible for the overall strategic direction and subject matter leadership for diagnostics. Carlos also spent 7 years at the Notified Body BSI, where he managed, coached, and developed a global team of IVD technical experts. He was BSI’s first in-house clinician for IVDs. He led the implementation of the BSI clinical oversight process, made hundreds of CE marking recommendations for IVDs and supported IVDR Notified Body designations. Prior to BSI, Carlos held roles at the UK competent authority, the MHRA, and was a lead scientist in the UK National Health System, specializing in transfusion and transplantation medicine. He played a key role in hospital and laboratory preparedness for emerging infectious diseases, including the Ebola crisis in 2014, when the first cases were detected in Europe.
Anna Eisenberg has 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for the company’s life science strategy and maintaining relationships with global leaders in the field. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines. She will cover the lasting benefits of working with an experienced life science LSP that will help increase security, organize workflow, save time in compliance, and reduces costs.