Simona B.

I am a Regulatory Affairs expert with extensive experience ensuring compliance in the design, development, and commercialization of medical devices in the EU and global markets. With a strong understanding of EU MDR 2017/745, MDD, AIMDD, and various international registration requirements, I offer expert guidance to manufacturers navigating complex regulatory landscapes.

Throughout my career, I have supported companies across a wide spectrum of medical device fields, including cardiovascular systems, dental implants and orthodontic devices, 3D-printed orthopedic implants, neurostimulators (AIMD), and medical software (SaMD). I develop and implement regulatory strategies for both new product development and changes to existing products, ensuring smooth market entry and continued compliance.

My services include writing and reviewing Technical Documentation, CE marking dossiers, and regulatory submissions; managing regulatory aspects of product changes; and supporting audits and inspections by regulatory authorities and notified bodies. I also provide training on regulatory changes and contribute to internal SOP development to meet evolving requirements.

With a hands-on approach, I collaborate with cross-functional teams to review/author technical protocols, labeling (IFU, labels, brochures, PIC/PIL), clinical evaluation report (CER, CEP) and post-market surveillance (PMS, PMCF, PSUR). Whether you need support with EU MDR transition, documentation preparation, or strategic regulatory planning, I bring precision, insight, and experience to help your projects succeed.