Compass Health AI SOP: Software Development
10 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

Which standard specifically relates to software life-cycle processes for medical devices?

  • ISO 13485:2016 Section 7.3 Design and Development
  • IEC 62304:2015 Medical Device Software – Software Life-cycle Processes (correct)
  • ISO 9001:2015 Quality Management Systems
  • FDA QSR § 820.30 Design Controls

    • What is the role of the Independent Reviewer in the software development process?

  • Conduct development of software requirements
  • Report on the status of software development to management
  • Provide final approval for process transitions
  • Review the design stage without direct responsibility for it (correct)

    • Which document number corresponds to the Standard Operating Procedure for Change Control?

  • QMS-SOP-0013
  • QMS-SOP-0007
  • QMS-SOP-0002
  • QMS-SOP-0014 (correct)

    • What acronym refers to the verification and validation process in the software development process?

    <p>V&amp;V</p> Signup and view all the answers

    What activity is NOT explicitly mentioned as part of the software development process at Compass Health?

    <p>Deployment</p> Signup and view all the answers

    What primary factor determines the classification of software safety under IEC 62304?

    <p>The possible effects on the patient or operator resulting from a hazard</p> Signup and view all the answers

    Which class of software indicates that no injury or damage to health is possible?

    <p>Class A</p> Signup and view all the answers

    If a piece of software is initially classified as Class C, what is required for continued development?

    <p>A significant risk reduction measure must be in place</p> Signup and view all the answers

    What does the Software Development Plan (SDP) primarily focus on?

    <p>Activities required to create a finished medical device software product</p> Signup and view all the answers

    Which of the following statements about Class B software is correct?

    <p>It allows for the possibility of non-serious injury</p> Signup and view all the answers

    Study Notes

    Compass Health AI SOP: Software Development

    • This document outlines the process and responsibilities for designing and developing software products at Compass Health Inc.
    • It applies to all software developed for medical device applications.
    • The SOP: Product Development Process describes the overall product development process, from research to end-of-life.
    • The SOP: Software Development outlines the software development activity during the 4 core product development phases.
    • It divides the development phase into three stages to facilitate implementation, validation, and verification.
    • The document aligns with IEC 62304 requirements.

    Applicable Standards

    • FDA QSR § 820.30 Design Controls are intended.
    • ISO 13485:2016 Section 7.3 Design and Development standards are intended.
    • IEC 62304:2015 Medical Device Software – Software Life-cycle Processes are intended.

    Process Roles

    • Project Manager: Reports on software development status at scheduled reviews.
    • Project Leader: Approves process transitions.
    • Engineers: Conduct requirements definition, development, verification, and validation.
    • Independent Reviewer: Conducts design reviews (independent of design teams).

    Software Development Process

    • The process encompasses planning and development activities.
    • Planning: Top level and system requirements are analysed for definition of software requirements, potential hazards, traceability and testability of requirements, security, feasibility of design and maintenance, external interfaces, and workflows.
    • Development: No development activities occur at the Project/Product level; all development happens at the Epic and Story levels.
    • Verification & Validation: Activities depend on software class (A, B, or C).
    • Review: Requirements are reviewed by Product and Engineering personnel, plus an Independent Reviewer.
    • Maintenance: No maintenance activities occur at the Project/Product level.
    • Release Level: This level comprises activities needed for a finished product, including documentation to show regulatory and quality system compliance.
      • Planning: Evaluation of Release suitability; change history from previous releases; and documenting required documentation.
      • Development: No development activities.
      • Verification & Validation: Ensuring system and I&T verifications are complete, documenting and evaluating any identified anomalies.
      • Review: A formal review to assess product suitability for release, materials, and compliance.
      • Maintenance: Maintenance activities are included at this level.
    • Unit Level: No software changes are made at this level, unit changes might lead to new firmware requirements.

    Acronyms and Definitions

    • I&T: Integration and Test
    • IEC: International Electrotechnical Commission
    • OS: Operating System
    • PDP: Product Development Plan
    • SDP: Software Development Plan
    • SOP: Standard Operating Procedure
    • SOUP: Software of Unknown Provenance
    • V&V: Verification and Validation

    Software Safety Classification

    • Software is classified as A, B, or C based on potential hazard/risk on patient and operator.
    • Class A: No injury or damage is possible.
    • Class B: Non-Serious Injury is possible.
    • Class C: Death or Serious Injury is possible.

    Primary Process Documentation

    • This section identifies the documentation generated in this SOP.

    Risk Management Plan Details

    • Software specific activities are included in the risk management plan.
    • SOUP anomaly lists are evaluated.
    • Risk control measures are documented in software requirements and are not used to reduce safety class.
    • Software changes are analyzed for introduction of additional hazards or mitigation measures impacting risk.

    Design Transfer

    • Activities include a Release Readiness Meeting (RRM), covering design, risk, usability, validation, and documentation.
    • Independent Reviewer is included in the RRM.

    Process Monitoring

    • Regular evaluation of software documentation ensures it aligns with SOP and SDP.
    • Results are communicated to Management during QMS Management Review meetings.

    Quality Records

    • Necessary records include checklists, phase gate transition checklists, and lists/descriptions of residual anomalies.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Related Documents

    Compass Health AI Software Development SOP PDF

    Description

    This quiz covers the Standard Operating Procedures for software development at Compass Health Inc., specifically for medical device applications. It outlines the product development process from research to end-of-life and highlights compliance with key standards such as IEC 62304. Participants will learn about the roles involved and the structured stages of software development within the organization.

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser