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Clinical Performance Study applications for IVDs in Spain
In vitro diagnostic medical devices (IVDs) are increasingly in demand as the medical technology evolves by leaps and bounds. With the application of
EU MDR risk management requirements: FMEA and ISO 14971 comparison
Historically, medical device manufacturers have frequently used Failure Modes and Effects Analysis (FMEA) to identify possible failures in
PER According to IVDR
Performance Evaluation The EU Regulation 2017/746, commonly referred to as In Vitro Diagnostic Medical Device Regulation (IVDR), imposes
List of Notified Bodies under IVDR (EU) 2017/746 on In-Vitro Diagnostic Medical Devices
A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is
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