Medical device feature management Apr 3, 2025 Oumaya Ibrahim Obtaining the CE marking for software as a medical device (MD) is a crucial step for market access in Europe. However, not all software features are intended for medical purposes. Distinguishing betwe... Regulatory Read more
PRRC: All you need to understand Mar 11, 2025 Oumaya Ibrahim The Regulation (EU) 2017/745 on Medical Devices (MDR) requires manufacturers to appoint a Person Responsible for Regulatory Compliance (PRRC) . This obligation applies to all medical device manufactur... Regulatory Read more
Everything you should know about internal audits: requirements, methods and benefits Mar 6, 2025 Oumaya Ibrahim Internal audits are often viewed as a simple formal requirement dictated by standards, but they go beyond mere compliance. A thorough internal audit helps pinpoint discrepancies, enhance the quality m... Quality Read more
