Tag

usability
Company: Advanced Bionics, LLC Date of Enforcement Report: 3/11/2020 Class III PRODUCT SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 – Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device...
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Company: Elekta, Inc. Date of Enforcement Report: 12/27/2018 Class II PRODUCT MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery Recall Number: Z-0686-2019 REASON If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup...
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SoftwareCPR® – Human Factors and Usability Engineering Assessment Does the design of your device promote safe and effective use? Are you ready for an FDA regulatory submission requiring HFE/UE report? Do you maintain a usability engineering file for your products? Is it complete? Do you have a systematic process for identifying and analyzing use error?...
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/docs/FDAhighestprioritydevices4humanfactorsreview0216.pdf
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HIT Implementation, Usability and Safety Workgroup meeting on Friday, February 6, 2015 – SoftwareCPR® Partners Sherman Eagles and Alan Kusinitz gave a presentation at ONC’s request with recommendations on an approach to HealthIT provider quality systems regulation and standards. In addition to providing background on quality systems, SoftwareCPR® recommended that a standard or guidance be...
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With the permission of Oliver Christ of PROSYSTEM AG in Hamburg, Germany, you can view or download slides at the link provided entitled: Cost-effective Application of Usability Engineering and Risk-Management. Oliver and his partner are heavily involved in standards and these slides provide an excellent overview of medical device usability, software, and risk management standards...
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
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