Leslie Hammermüller is a clinical project manager and medical writer specialising in clinical, regulatory, and post‑market requirements for medical devices across all risk classes. With more than a decade of experience in clinical research, data management, and clinical affairs, she supports manufacturers in meeting the complex clinical evidence obligations of EU MDR 2017/745 and IVDR 2017/746.
Her background in human biology and prior roles as Clinical Data Manager in a global CRO and as Clinical Affairs Manager at a medical device manufacturer provide her with a comprehensive understanding of both sponsor and service‑provider perspectives.
At AKRA TEAM, Leslie advises on clinical evaluation, PMS, PMCF, project management, and SOP development, ensuring robust data integrity and regulatory compliance. She is also an active speaker and trainer at professional events, focusing on clinical data, post‑market surveillance, and evolving regulatory expectations.