Key resources include regulatory references, existing software tools, and the OpenMind OS-QMS.
➜ Working in the context of an active IDE protocol? Check with your team lead and IDE documentation to assess FDA expectations for application of Design Controls and Quality Management in the development of software, especially for Software as a Medical Device.
🟠 Learn about Software as a Medical Device here
🟠 Read a high-level introduction to Design Controls (best practice for all software projects) and Quality Systems in the OS-QMS “COMPASS” document here. FDA Guidance on Design Controls can be found here.
🟠 Review available software tools and documentation found in the OpenMind Github repositories here
🟠 Access the OpenMind OS-QMS, including specialist-annotated templates for Design History File, Device Master Record and SOP documentation, here
Review key regulatory references, existing OpenMind IDE protocol and FDA examples, and, as applicable, the OpenMind OS-QMS.
➜ Working in the context of an active IDE protocol? Does your project potentially include the development of hardware or software tools? Check with your team and your study’s IDE documentation to assess FDA expectations for application of Design Controls and Quality Management in the development of hardware and software, including Software as a Medical Device. See “Software Engineers” toolkit, above, for more information.
🟠 Follow links here to get acquainted with FDA Guidance documents particularly relevant to IDE studies:
• “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies” (link)
• “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” (link)
• Information Sheet - Significant Risk and Non-Significant Risk Medical Devices (link)
• “Guidance for Industry: Investigator Responsibilities - Protecting the Rights, Safety and Welfare of Study Subjects” (link)
• “Sponsor’s Responsibilities for Significant Risk Device Investigations” (link)
• “FDA Decisions for Investigational Device Exemption Clinical Investigations” (link)
🟠 Review existing OpenMind IDE protocol and FDA correspondence examples here
🟠 Tour the OpenMind OS-QMS here, beginning with the “COMPASS” overview document, to learn how Design Controls and Quality Systems fit into the IDE process.
🟠 Funders, including NIH, as well as FDA increasingly view and expect team-wide awareness of neuroethics considerations as an integral component of IDE studies. Review a collection of relevant references and resources collected by OpenMind here.
Working with patients, devices and data? Be sure to check out key OpenMind tools and resources to make your work more efficient and effective.
🟠 Review available software tools and documentation found in the OpenMind Github repositories here
🟠 Review existing OpenMind IDE protocol and FDA correspondence examples here
🟠 Funders, including NIH, as well as FDA increasingly view and expect team-wide awareness of neuroethics considerations as an integral component of IDE studies. Review a collection of relevant references and resources collected by OpenMind here.