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More Articles related to Medical Device Software

IT-Security: Medical device manufacturers must ensure the IT security of their devices. Regulations such as the FDA cybersecurity guidance documents demand a systematic approach
Artificial Intelligence: The artificial intelligence is applied in medicine as well. Medical devices have been developed and must comply with regulatory requirements.
Parameterization: Parametrization of software seems promising: Fullfilling individual customer requirements with just one application. Mind the legal implications. Read how!
Creating standard operating procedures for QM: In a standard operating procedure (SOP), companies define their processes, for example how they develop medical devices or provide services.
Validation of Machine Learning Libraries: Validation of Machine Learning Libraries, mdr, ivdr, IEC 62304, ISO 13485, validation, device development, best practices
Anonymization and Pseudonymization: In a standard operating procedure (SOP), companies define their processes, for example how they develop medical devices or provide services.
IEC 60601-4-5: The standard family IEC 60601 is actually only applicable to medical electrical devices. But IEC 60601-4-5 is an exception: This standard for IT security has all medical products in the scope that they are integrated into IT networks. This also affects software as a medical device.
CVSS – Common Vulnerability Scoring System: In IT security, Common Vulnerability Scoring Syste, CVSS, classify the degree of severity of software vulnerabilities, assess these vulnerabilities
Medical grade software: medical device distributor, medical grade software, software, medical, grade, classification of software as a medical device, health software
ISO 27034 on Application Security: ISO 27034 on Application Security: Reading It = A Waste of Time?, IT security is a regulatory requirement, DiGAV, state of the art,
Machine Learning at Banks: Machine Learning at Banks, medical device manufacturers, Banking regulations,Stricter regulation of algorithms, digitalization
ISO 27001: ISO 27001, IT Security Management for all Medical Device Manufacturers?, iso 27001 requirements, iso 27001 affecting, ISMS
Transfer Learning in Medical Devices: Transfer Learning , Medical Devices, Deep neural networks, pre-trained models, Risks of transfer learning, suboptimal modal
ISO/IEC TR 29119-11 on Testing AI/ML Software?: At the end of 2020, ISO published the technical report ISO/IEC TR 29119-11. Its title is “Guidelines on the testing of AI-based systems”.