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Digital Transformation - Fit-for-future-Program  
Moving away from the document transfer station and regulatory uncertainty towards a regulatory affair that is "fit for future" Important note: The first run of the Fit for Future Program…  
Phantoms in medical technology  
Phantoms in medical technology Phantoms in medical technology help to develop, validate, "approve" and monitor medical devices in the markets faster and more effectively.  This article…  
IT-Security in Healthcare  
IT Security in Healthcare We have known how vulnerable IT security is in the healthcare sector since February 2016, when the IT infrastructures of many clinics were brought to a standstill by a…  
IEC/TR 60601-4-5: The standard for IT security, is it also for stand-alone software?  
IEC/TR 60601-4-5: The standard for IT security, is it also for stand-alone software? The standard family IEC 60601 is actually only applicable to medical electrical devices. But…  
Risk management in hospitals and at other operators  
Risk management in hospitals and at other operators Laws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. …  
Risk management plan: The most important advantages  
Risk management plan: The most important advantages The risk management plan is one of the most important documents in technical documentation. Accordingly, authorities and notified bodies…  
Harmonized Standards  
Harmonized standards: Evidence for medical device manufacturers Most medical device manufacturers benefit from harmonized standards to demonstrate compliance of their medical devices with the…  
EU Data Act: Hand over the data!  
The EU Data Act obliges providers of many devices and services to provide users with extensive data. A danger!  
What Manufacturers Need to Know about Legacy  
What Manufacturers Need to Know about Legacy Devices Legislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR)…  
EUDAMED: European Databank on Medical Devices  
EUDAMED: European Database on Medical Devices EUDAMED is the European database for medical devices. However, it is not only used to manage medical devices. The Medical Device Regulation (MDR)…  
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