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 management system (QMS), and prepare for external audits, particularly those conducted by notified bodies under the MDR 2017/745 regulation. ISO 13485:2016 ISO 13485:2016 is the international…
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 between MD and non-MD features is essential to ensure compliance with the requirements of Regulation (EU) 2017/745 (MDR) and to maintain accurate regulatory documentation….
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 manufacturers, including those developing Software as a Medical Device (SaMD). For small businesses and start-ups, this requirement may seem burdensome due to limited resources and the complexity of regulatory…