Compass Health SOP: Product Development Process

Approvals and History

• Document is titled "Compass Health Al SOP: Product Development"
• Version 1.0, initial release on 03-Jan-2024
• Authors and roles/positions are listed in an approvals section
• Tenzin Yangzom, Head of QA/RA, was the author
• James Baskin, COO, was the approver
• Rushabh Gudka, Head of Product, was the approver

Product Development Process

• A phase-based process with defined inputs/outputs and criteria
• Document outlines the process used at Compass Health, including phases, tasks, documentation, and responsibilities
• SOP: Product Development Process follows for all medical devices developed internally at Compass Health
• SOP covers stages from Concept to End-of-Life
• Major device/system changes are covered
• Minor changes (maintenance/firmware) managed by SOP: Change Control (QMS-SOP-0014)
• Guidance on stage transition criteria, risk management, validation, design, and clinical plans is provided.
• Process does not apply to work done in the Research and Development phase
• Includes a detailed process flow diagram.

Applicable and Reference Documents

• Standards and Regulations

  • FDA QSR § 820.30 Design Controls
  • ISO 13485:2016 Section 7.3. Design and Development
  • IEC 62304:2015 Medical Device Software – Software Life-cycle Processes
  • IEC 63266:2015 Medical devices

• Other Documents

  • SOP: Usability Engineering Process (QMS-SOP-0011)
  • Risk Management Plan and Report Template (CLR-PLN-0002)
  • Usability Engineering Plan and Report Template (CLR-PLN-0003)
  • SOP: Change Control (QMS-SOP-0014)
  • SOP: Risk Management (QMS-SOP-0013)
  • SOP: Software Development Process (QMS-SOP-0008)
  • SOP: Production (QMS-SOP-0012)
  • SOP: Document Controls (QMS-SOP-0002)
  • CLR-REC-0007

Process Roles

• Product Manager: Defines product strategy, detailed user stories, and reports on development status
• Project Manager: Reviews phase deliverables and risk management, decides on next phase transitions
• QA-RA: Conducts regular product documentation evaluations, identifying misalignments

Product Development Process

• The process involves multiple phases across the product lifecycle.
• Shows a typical sequence from Research & Development to End of Life
• Each phase has specific entry and exit criteria.

Phase Transitions

• A project starts in Research or Product Design & Concept phases
• The project manager determines the start phase
• Project review based on deliverables, risk status, guides phase transitions
• Checklists document these decisions

Phase Entry/Exit Criteria

Detailed descriptions of entry and exit criteria for each phase

Documentation

• Includes detailed requirements for documentation in each phase of the development life cycle
• Outlines what forms, plans, reports, and documents of each phase need to be completed.

Quality Records

• Phase transition checklists are included as Quality Records.
• Results/status of documentation reviews are communicated to Management

This quiz explores the Standard Operating Procedure (SOP) for the Product Development Process at Compass Health. It covers the phases, responsibilities, and criteria involved in the development of medical devices. The documentation serves as a guide for transitioning from concept to end-of-life for these products.