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The most frequently asked questions about the quality management system  
The most frequently asked questions about the quality management system   This FAQ provides answers to the most common questions that companies such as medical device manufacturers have about  
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SBOM: Software Bill of Materials  
SBOM: Software Bill of Materials   Laws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always  
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Level of Concern: What the FDA wants to achieve with it  
Level of concern and documentation level: What the FDA wants to achieve with it The FDA distinguishes between three so-called "Levels of Concern," which are very reminiscent of the safety classes  
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Software Lifecycle  
Software life cycle: What is meant by this?   The Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Devices Act before it) requires manufacturers t  
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DAkkS: What's behind the outrage about ISO 13485?  
DAkkS: What's behind the outrage about ISO 13485? The DAkkS, the German Accreditation Body, is Germany's national accreditation authority. Recently, manufacturers, associations, and certificati  
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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 des  
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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 sim  
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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 IEC/  
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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 examin  
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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 gen  
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