A new draft of IEC 62304 has been created
A draft of Edition 2 of IEC 62304 has been produced. IEC 62304 Medical device software — Software life cycle processes establishes life cycle requirements for development of medical device software.
Although it is not
Timetable for EMA advice to medical device manufacturers
The European Medicines Agency (EMA) has published its timetable concerning the Agency’s procedure for providing advice to medical device manufacturers. This advice procedure, which is based on Article 54 of the Medical Devices Regulation (MDR), is intended to