Medical Imaging Software – What Clinicians need
Medical imaging software is developed for clinicians. Do you know what requirements these professional users have? Here a user tells you!
Medical imaging software is developed for clinicians. Do you know what requirements these professional users have? Here a user tells you!
Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.
Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks?
Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.
Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.
Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.
Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).