Medical device approval
The approval of medical devices in Europe according to EU MDR 2017/745 or other regulations, e.g. USA according to 21 ...
Quality management
EN ISO 13485 - Quality management for medical devices Quality management is more than just an ISO standard or a ...
Risk management
EN ISO 14971 - Risk management for medical devices Risk management covers the entire life cycle of a medical device ...
Conformity assessment for medical devices
Medical devices must undergo a conformity assessment in the EU, EEA and Switzerland in accordance with EU MDR 2017/745. This ...