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Regulatory Roundup

February 16, 2023 | Virtual

We are pleased to announce that we are joining Regulatory Roundup as sponsors and speakers. This unique event is hosted by MassMEDIC, the largest regional medtech association in the United States.

Regulatory Roundup is designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry. The agenda includes comprehensive presentations by CDRH, industry representatives and regulatory experts.

Join our colleague Ainoa Forteza, Associate Director of Regulatory, for a session “Navigating MDR Today and Tomorrow”. The session will be moderated by Mercè Guerra, our Regulatory Affairs Manager.

About the session “Navigating MDR Today and Tomorrow””

This interactive presentation will provide you with an overview of the latest updates on MDR in the EU, including the impact to global medical device regulatory developments due to the proposed transition period for compliance. Join us to hear what will happen next for MDR and how you can best navigate the evolving global regulatory environment.

Events

Category:

Regulatory

Published on:

February 10, 2023

About Our Speakers:

Ainoa Forteza

Associate Director of Regulatory Ainoa Forteza is a Regulatory expert on Medical Devices and In Vitro Diagnostics. She helps companies develop their MedTech products according to the applicable regulatory requirements, with a special mention to MDR and IVDR. With 7+ years of experience in industry, Ainoa’s previous roles include positions at consulting firm (DDR, currently Veristat) where she oversaw the team responsible for Medical Devices and In Vitro Diagnostics.

Mercè Guerra

Regulatory Affairs Manager Mercè Guerra joined Alira Health in 2021 after several years of experience in regulatory affairs in Medical Devices and In Vitro Diagnostics as part of Drug Development and Regulation S.L. (DDR, now Veristat).

Mercè has a bachelor degree in Human Biology and a Master’s Degree in Pharmaceutical and Biotechnology Industry, both from Universitat Pompeu Fabra (UPF). Mercè expertise lies in MD/IVD strategy and regulatory activities, including CE Mark, CER, pre-RFD, 510(k), PreSubs, BDD, 513 (g), De Novo request, among others. Mercè has also been involved in the development of drugs for a wide range of indications and has expertise on EMA-related activities such as Scientific Advice, Orphan Drug Designation and Briefing Meetings.