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    • Third edition of ISO 14971
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    • Main Operating Functions
    • ISO 9241
    • User stories
    • Usability Validation
    • Heuristic Evaluation
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    • Intended Use Description
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    • Clinical Evaluation
    • Verification versus Validation
    • Biocompatibility - ISO 10993
    • And more ...

More Articles related to Medical Device Software

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.
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

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