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19 Result(s)

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  1. Book Series

    Reference Series in Biomedical Engineering

  2. No Access

    Living Reference Work Entry In depth

    Manufacturing and Quality Assurance in Compliance with the MDR and IVDR

    Medical devices and in vitro diagnostic medical devices must be designed and manufactured in such a way that they are fit for their intended purpose and achieve their specified performance under normal conditi...

    Johann Harer in Medical Devices and In Vitro Diagnostics

  3. No Access

    Living Reference Work Entry In depth

    Integrated Qualification of Manufacturing Systems for Medical Devices

    It is recommended that industrial manufacturing systems that produce medical devices are managed throughout the whole life cycle according to Good Manufacturing Practice in order to allow products to be brou...

    Clemens Borkenstein, Marie-Astrid Haibl… in Medical Devices and In Vitro Diagnostics

  4. No Access

    Living Reference Work Entry In depth

    Validation of Methods and Analytical Processes for In Vitro Diagnostics

    Method validation is described as the process of confirming that the analysis used for a particular diagnostic test procedure is suitable for obtaining the specified intended use. Manufacturers can use the res...

    Karin Schwenoha, Johann Harer in Medical Devices and In Vitro Diagnostics

  5. No Access

    Reference Work Entry In depth

    Integrated Qualification of Manufacturing Systems for Medical Devices

    It is recommended that industrial manufacturing systems that produce medical devices are managed throughout the whole life cycle according to Good Manufacturing Practice in order to allow products to be brou...

    Clemens Borkenstein, Marie-Astrid Haibl… in Medical Devices and In Vitro Diagnostics (2023)

  6. No Access

    Reference Work Entry In depth

    Process Validation for Medical Device Manufacturing

    Medical devices cover a wide range of different technologies and applications from simple surgical instruments to complex surgical robots, from implants to artificial organs, and from blood glucose monitoring ...

    Johann Harer in Medical Devices and In Vitro Diagnostics (2023)

  7. No Access

    Living Reference Work Entry In depth

    Quality Management Requirements in Compliance with European Regulations

    Quality management is a central requirement in the area of medical and in vitro diagnostics devices. Based on the new European regulations, it is mandatory for all manufacturers, regardless of the risk class o...

    Johann Harer, Jörg Schröttner in Medical Devices and In Vitro Diagnostics

  8. No Access

    Book and Reference Work

    Medical Devices and In Vitro Diagnostics

    Requirements in Europe

    Christian Baumgartner, Johann Harer… in Reference Series in Biomedical Engineering (2023)

  9. No Access

    Reference Work Entry In depth

    Mastering Quality System Audits and Inspections for Medical Devices

    Medical and in vitro diagnostic devices shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose and they shall not compromise the cl...

    Andrej Smogavc Cestar, Johann Harer in Medical Devices and In Vitro Diagnostics (2023)

  10. No Access

    Living Reference Work Entry In depth

    Mastering Quality System Audits and Inspections for Medical Devices

    Medical and in vitro diagnostic devices shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose and they shall not compromise the cl...

    Andrej Smogavc Cestar, Johann Harer in Medical Devices and In Vitro Diagnostics

  11. No Access

    Reference Work Entry In depth

    Quality Management Requirements in Compliance with European Regulations

    Quality management is a central requirement in the area of medical and in vitro diagnostics devices. Based on the new European regulations, it is mandatory for all manufacturers, regardless of the risk class o...

    Johann Harer, Jörg Schröttner in Medical Devices and In Vitro Diagnostics (2023)

  12. No Access

    Living Reference Work Entry In depth

    Post-Market Surveillance and Vigilance on the European Market

    Manufacturers of medical devices must ensure that their products placed on the market meet the promised performance during their intended use and do not pose a risk to users, patients, and the general public. ...

    Johann Harer in Medical Devices and In Vitro Diagnostics

  13. No Access

    Reference Work Entry In depth

    Validation of Methods and Analytical Processes for In Vitro Diagnostics

    Method validation is described as the process of confirming that the analysis used for a particular diagnostic test procedure is suitable for obtaining the specified intended use. Manufacturers can use the res...

    Karin Schwenoha, Johann Harer in Medical Devices and In Vitro Diagnostics (2023)

  14. No Access

    Living Reference Work Entry In depth

    Process Validation for Medical Device Manufacturing

    Medical devices cover a wide range of different technologies and applications from simple surgical instruments to complex surgical robots, from implants to artificial organs, and from blood glucose monitoring ...

    Johann Harer in Medical Devices and In Vitro Diagnostics

  15. No Access

    Reference Work Entry In depth

    Manufacturing and Quality Assurance in Compliance with the MDR and IVDR

    Medical devices and in vitro diagnostic medical devices must be designed and manufactured in such a way that they are fit for their intended purpose and achieve their specified performance under normal conditi...

    Johann Harer in Medical Devices and In Vitro Diagnostics (2023)

  16. No Access

    Reference Work Entry In depth

    Post-Market Surveillance and Vigilance on the European Market

    Manufacturers of medical devices must ensure that their products placed on the market meet the promised performance during their intended use and do not pose a risk to users, patients, and the general public. ...

    Johann Harer in Medical Devices and In Vitro Diagnostics (2023)

  17. No Access

    Reference Work Entry In depth

    Management for Critical Medical Device and IVD Suppliers

    Medical device manufacturers bear ultimate responsibility that their devices are safe and work according to their specifications. It does not matter whether they develop or produce their products by their own ...

    Johann Harer in Medical Devices and In Vitro Diagnostics (2023)

  18. No Access

    Living Reference Work Entry In depth

    Management for Critical Medical Device and IVD Suppliers

    Medical device manufacturers bear ultimate responsibility that their devices are safe and work according to their specifications. It does not matter whether they develop or produce their products by their own ...

    Johann Harer in Medical Devices and In Vitro Diagnostics

  19. No Access

    Book and Living Reference Work (Continuously updated edition)

    Medical Devices and In Vitro Diagnostics

    Requirements in Europe

    Christian Baumgartner, Johann Harer… in Reference Series in Biomedical Engineering