Celeste Oliveira

Celeste Oliveira (F), MSc, has a master degree in Regulation and Evaluation of Medicines and Health Products from University of Lisbon and graduated in Biomedical Sciences from University of Aveiro. Celeste has experience in pharmacovigilance, namely clinical and scientific literature search and ICSR submission and since 2019 has experience in medical devices regulation and quality management systems related to medical devices. In 2022 became an ISO 13485 auditor, conducting audits according to EN ISO 13485 and EN ISO 9001 standards, including applicable standards like ISO 14971. Celeste has experience in writing clinical evaluation reports for class I, class IIa and class IIb medical devices. Since 2021, Celeste is acting as medical devices and in vitro diagnostics regulatory expert, in the Laboratory for Automation and Systems from Instituto Pedro Nunes, helping companies to certify their MD and IVD products (CE marking and FDA clearance), including standalone software, non-invasive class I, class IIa and class IIb and active medical devices. As a part of the regulatory unit, Celeste has supported more than 20 companies throughout their devices regulatory process.