Compass Health AI Product Development SOP PDF

Compass Health AI SOP: Product Development Approvals Document# QMS-SOP-007 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024...

Compass Health AI SOP: Product Development Approvals Document# QMS-SOP-007 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document# QMS-SOP-007 1 Introduction Product development is a phase-based process with a defined set of input and exit criteria. This document outlines the product development process used at Compass Health, including planned phases, tasks, documentation, and responsibilities within each phase. 1.1 Scope The SOP: Product Development Process shall be followed for all medical device products that are internally designed and developed by Compass Health. The product development process is part of the Compass Health Quality Management System. This SOP provides guidance on definition of stage transition criteria, and incorporation of risk management, verification and validation, design and development, and clinical plans into the Product Development Plan. Deviations from this SOP shall be documented in the Product Development Plan. This process does not apply to work done in the Research and Development phase defined herein. All phases of product development, from Concept to End-of-Life are covered. Major device and system level changes to existing products are covered by this SOP. Minor changes, such as maintenance or minor firmware updates are handled by the SOP: Change Control (QMS-SOP-0014). 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: FDA QSR § 820.30 Design Controls Document# QMS-SOP-007  ISO 13485:2016 Section 7.3. Design and Development IEC 62304:2015 Medical Device Software – Software Life-cycle Processes IEC 63266:2015 Medical devices – Application of usability engineering to medical devices 2.2 Reference Documents Document Title Document # SOP: Usability Engineering Process QMS-SOP-0011 Risk Management Plan and Report Template CLR-PLN-0002 CLR-PLN-0003 Usability Engineering Plan and Report Template CLR-REC-0007 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 3 Acronyms and Definitions Table 1: Acronyms Document# QMS-SOP-007  Acronym Description BOM Bill of Materials CAPA Corrective and Preventative Action PDP Product Development Plan QA Quality Assurance SOP Standard Operating Procedure 4 Process Roles Role Description Defines the product strategy, designs the detailed user Product Manager stories, and reports on the status of Product Development at regularly scheduled reviews with Management With input from the project team members, and after reviewing the phase deliverables and risk management status, decides when to move to the next phase in the Project Manager product development process *Can also report on the status of Product Development at regularly scheduled reviews with Management QA-RA Conduct regular evaluation of the status of product documentation, identifying any elements not aligned with Document# QMS-SOP-007  this SOP or the Product Development Plan for the given product. Defines the Go to Market strategy, projected lifetime of the product considering inputs such as engineering determination, trending of customer feedback on previous Marketing Compass Health product and/or predicates, industry review (marketing intelligence) and literature review of past products/predicates. Responsible for translating the device design into Operations production specifications (e.g. work instructions, BOM) in the pre-production phase Communicates the results of reviews and status of Management documentation and reviewed at each regularly scheduled QMS Management Review meeting 5 Product Development Process The Product Development Process involves multiple phases throughout the product lifecycle. Nominally, a product shall follow the following sequence of phases, described below and shown in Figure 1: 1. Research and Development 2. Product Concept & Design 3. Development 4. Verification/Testing 5. Validation and Pre-Production 6. Production & Support 7. End of Life Document# QMS-SOP-007 Each phase will comprise defined work and documentation, as well as reviews including appropriate personnel, as a gate on proceeding to the next phase. Records of all phase gate reviews shall be kept. In addition to the documentation produced within each phase, the following cross-cutting documentation shall be created, controlled, and managed throughout every phase of the product development, beginning with Product Concept: 8. Product Development Plan 9. Risk Management Plan 10. Usability Engineering Plan Figure 1: Product Development High Level Process 5.1 Phase Transitions A project can begin in any of the first two phases: Research, or Product Design & Concept. The starting phase for a project shall be identified when the project manager is assigned. The project manager, with input from the project team members, and after reviewing the phase deliverables and risk management status, decides when to move to the next phase in the product development process. A checklist form for the relevant phase transition shall be completed to document the phase deliverables for the project and to approve the transition decision. The checklist is stored as a controlled record (per SOP: Control of Records [QMS-SOP-0003]) and referenced in the Design History File. 5.2 Research and Development Phase Research and preliminary development activities precede the formal Product Development Process and provide the basis for the product concept and design. Research is an ongoing process with potential needs progressing into the later stages of the product Document# QMS-SOP-007 development process at the discretion of Compass Health. Documentation in this phase is considered outside the scope of this process. Phase Entry Criteria: None – Resources assigned by executive management. Product concept ideas come from potential or existing customers, clinical investigators, research and market analysis. Phase Tasks: Out of scope for Product Development Process. Exploration of product ideas may include design prototyping, early software prototypes, literature reviews, investigation of technology, and clinical requirements analysis, as appropriate. Phase Documentation: Out of scope for Product Development Process. Documentation of prototypes, literature reviews, technology investigations, requirements analysis, as appropriate. Phase Exit Criteria: Decision to abort or begin product development process based on business evaluation and results of prototype developments, as appropriate 5.3 Product Design & Concept Phase This phase of the product development process is where the design of the product begins to take shape. In this phase, the product manager(s) builds business requirements, conducts market analysis and runs discovery sessions with the intended users to build a high-level product design. The high-level design is broken into user stories to cover all product usage scenarios. Prototype development may be done and at design review for this phase, the prototype design is reviewed to determine what components of the prototype, if any, will be carried forward and used in the development phase. Phase Entry Criteria: Business decision to begin product development under this process Market analysis completed Phase Tasks: Document# QMS-SOP-007  Determine business and product requirements Determine baseline product architecture or product structure Build product design and user stories Define product development plan, with prioritized backlog Establish Usability Engineering file Establish Risk Management file Phase Documentation: Baselines for the following documentation shall be generated in this phase: Product Requirements Document Product Architecture or Product Structure Definition Product Design Product User Stories Product Development Plan, with prioritized backlog Project Risk Summary Statement System Requirements Document Usability Engineering Plan Risk Management Plan Product Hazard Analysis Note: Some of the above documentation items may be included in the Product Development Plan. Phase Exit Criteria: Successful Review of readiness and prioritized product backlog to proceed with development Successful review of the design stage by an Independent Reviewer Completed Form: Checklist – Transition to Development 5.4 Development Phase The Development phase is the section of the Product Development Process where the product design input (requirements, user stories, etc.) is translated into a technical design specification, and then developed. For software products, typically the development cycle consists of iterative milestones (refer to SOP: Software Development Process (QMS-SOP- 0008) for details). For physical products, development typically follows a standard Document# QMS-SOP-007 waterfall process. The Product Development Plan may define differing phase tasks and criteria, with appropriate justification for the divergence from this process. Phase Entry Criteria: Completed Form: Checklist – Transition to Development Preliminary Usability Engineering File Preliminary Risk Management File (including Product Hazard Analysis document) Product requirements, design and user stories defined (depending on scope of project, may be a System Requirements document or a partner’s requirements document). The source of the requirements is defined in the PDP. Product Development Plan, with a prioritized backlog Phase Tasks: Update Product Requirements Document as required Update System Requirements and Product Architecture / Product Structure Documents as required Determine lower-level technical requirements Create technical design specifications to meet requirements Implement technical design Perform software and/or hardware development Re-evaluate product hazards and risks Define production and build requirements Phase Documentation: The following documentation shall be created and/or updated in this phase: Software Requirements Documents and (Note: for software-only products, the System Requirements/Design and Software Requirements/Design may be the same set of documents) Design Spec Documents (for physical products) Technical Spec Documents (for software products) Component Spec Documents (for physical products) Testing, Verification and Validation Plans Unresolved Anomalies Report Preliminary User Documentation Product Development Plan, including update of the following sections: Document# QMS-SOP-007  o Quality o Regulatory and Clinical o Operations. For products which require production or manufacturing, a Production Plan draft shall be completed and referred to in the Operations section of the PDP. o Marketing Plan (including definition of the projected lifetime of the product) o Service Usability Engineering File (including update of Usability Engineering Plan and Report) Risk Management File (including updated Risk Management Plan, and Product Hazard Analysis) Note: Some of the above exit criteria items may be included in the Product Development Plan. Phase Exit Criteria: Successful Review of readiness to proceed with verification activities Design specification tested, verified and validated with no critical issues Completed Form: Checklist – Transition to Verification Note: The Quality, Operations and Service plan in the PDP shall consider the requirements of the Production process, as outlined in the SOP: Production (QMS-SOP-0012). Note: Marketing shall define the projected lifetime of the product, considering inputs such as engineering determination, trending of customer feedback on previous Compass Health product and/or predicates, industry review (marketing intelligence) and literature review of past products/predicates. 5.5 Verification Phase The Verification phase is the section of the Product Development Process where the product design input (requirements, user stories, etc.) translated into a technical design specification and developed is tested / verified. In this phase, the product developed into a tangible entity is shown to meet the defined requirements and specifications. For software products, typically the development cycle consists of iterative milestones (refer to SOP: Document# QMS-SOP-007 Software Development Process (QMS-SOP-0008) for details). For physical products, development typically follows a standard waterfall process. The Product Development Plan may define differing phase tasks and criteria, with appropriate justification for the divergence from this process. Phase Entry Criteria: Completed Form: Checklist – Transition to Verification Preliminary Usability Engineering File Preliminary Risk Management File (including Product Hazard Analysis document) Product requirements, design and user stories defined (depending on scope of project, may be a System Requirements document or a partner’s requirements document). The source of the requirements is defined in the PDP. Product Development Plan, with a prioritized backlog Phase Tasks: Update Product Requirements Document as required Update System Requirements and Product Architecture / Product Structure Documents as required Perform Testing/Verification of design and user stories Re-evaluate product hazards and risks Define production and build requirements Phase Documentation: The following documentation shall be created and/or updated in this phase: Software Requirements Documents and (Note: for software-only products, the System Requirements/Design and Software Requirements/Design may be the same set of documents) Testing/Verification Plans Component Acceptance Test Plan and Records Verification Results & Reports Unresolved Anomalies Report Preliminary User Documentation Product Development Plan, including update of the following sections: o Quality o Regulatory and Clinical Document# QMS-SOP-007  o Operations. For products which require production or manufacturing, a Production Plan (see Template: Production Plan) draft shall be completed and referred to in the Operations section of the PDP. o Marketing Plan (including definition of the projected lifetime of the product) o Service Usability Engineering File (including update of Usability Engineering Plan and Report) Risk Management File (including updated Risk Management Plan, and Product Hazard Analysis) Note: Some of the above exit criteria items may be included in the Product Development Plan. Phase Exit Criteria: Successful Review of readiness to proceed with validation and pre-production activities Design specification tested, verified and validated with no critical issues Completed Form: Checklist – Transition to Validation & Pre-production 5.6 Validation and Pre-production Phase The validation and pre-production phase is the phase of the product lifecycle where operations, quality and all other support groups prepare for the production, sale, distribution, installation and servicing of the final product. Operations is responsible for translating the device design into production specifications (e.g. work instructions, user training, BOM) in this phase. The activities in the validation phase will establish that product consistently meet the requirements are produced and that all supporting documentation and procedures accomplish their intended tasks. The Quality, Operations and Service plan in the PDP shall consider the requirements of the Production process, as outlined the SOP: Production (QMS-SOP-0012). Phase Entry Criteria: Completed Form: Checklist – Transition to Validation & Pre-production Development phase closure documented in design history file. Phase Tasks: Document# QMS-SOP-007  Develop production processes, and procedures, if applicable (e.g. in-house production) Identify and validate all production processes Perform Validation of design and user stories, if appropriate Identify and validate all process equipment Identify and create required Work Instruction training materials Identify and evaluate suppliers for production Obtain regulatory approval or registration as required Define user and service activities Update Product Development Plan (including update of Marketing Plan as appropriate) Re-evaluate product hazards and risks Phase Documentation: The following documentation will be created and updated in this phase, as applicable: Production Plan (including sampling plan for lot fitness as appropriate) Production Process Validation Report(s) (including production qualification run) Production Equipment Validation Report All component/part specifications and first article inspection reports Production Work Instructions Records of Work Instruction training Supplier Approval Records Validation Test Plan, if appropriate Validation Results and Report, if applicable Service Manual (including installation documentation) Service and Installation Validation Report Regulatory Approvals or Registrations Final User Documentation Release Notes, if applicable Device Master Record and BOM Usability Engineering File (including updated Usability Engineering Plan and Report) Risk Management File (including updated Risk Management Plan, and Product Hazard Analysis) Note: Some of the above exit criteria items may be included in the Product Development Plan. Document# QMS-SOP-007 Phase Exit Criteria: Successful Review of readiness to proceed with production activities Completed Form: Checklist – Transition to Production 5.7 Production and Support Phase The production phase of the product development process encompasses all of the activities after the design has been completed. These activities include the manufacturing, marketing, distributing, installation, servicing and disposing of the product. The production phase includes such quality functions as complaint handling, continued corrective and preventive action, and risk management for support and production of the product. Phase Entry Criteria: Completed Form: Checklist – Transition to Production Pre-Production concept phase closure documented in design history file Phase Tasks: Establish Complaint Handling file. Establish Distribution Records. Evaluate product lot fitness for sale (primarily for physical products) Release lots for sale which meet quality, safety, and effectiveness requirements Track product usage metrics Phase Documentation: Product Support Strategy Product Development Plan update including updates to the End of Product life strategy, and Service Plan encompassing the Field Upgrade Strategy. Customer / User Complaint Records Product usage metrics and reports Distribution Records Product Lot Release Records CAPA Investigation Records Phase Exit Criteria: Closure of all open complaint / CAPA investigations Document# QMS-SOP-007 5.8 End of Life The End-of-Life phase marks the closure and completion of all company activities in relation to the Product. Records are retained beyond the transition, according to SOP: Control of Records (QMS-SOP-0003) and SOP: Document Controls (QMS-SOP-0002). Phase Entry Criteria: Project Directive, as defined in product Marketing Plan (see Section 5.3) Phase Tasks: None Phase Documentation: None Phase Exit Criteria: Not Applicable Note: If Compass Health desires to resurrect a product past end-of-life, it shall be considered a new product development, and all product phases from Product Concept onward shall be revisited. It is likely that much of the product development work remains applicable, however this shall be reviewed and verified explicitly to ensure compliance with any new regulations, standards, processes, and requirements that may exist at such time. 6 Primary Process Documentation The following documentation forms the primary documentation output of this process specifically. While the various product phases call out other documentation, they are considered outputs of the product development itself, arising from the Product Development Plan. 6.1 Product Development Plan (PDP) The Product Development Plan includes assignment of responsibility and interfaces between groups for implementation of design, development and testing activities. It identifies and describes major tasks, Project milestones and key decision points. Document# QMS-SOP-007 The Product Development plan shall include a work breakdown, and shall include sections for the following plans: Product Design and User stories Technical Software Design Software Development Risk Management (see SOP: Risk Management (QMS-SOP-0013)) Usability Engineering (see SOP: Usability Engineering (QMS-SOP-0011)) Quality Regulatory and Clinical Service Operations Marketing Information Development (e.g. user manual, service manual) For large projects, any of the plans mentioned above may be documented in a separate document (and in that case, the Product Development Plan refers to the separate plan). The functional plans will be completed at the appropriate phase. For any phase deliverables or sections that are not applicable to the project, the justification is included in the relevant checklist (see the Checklist Forms for phase transitions). The product development plan shall be reviewed and updated at the end of each product development phase, prior to the phase review. 6.2 Risk Management Plan The Risk Management Plan is developed in accordance with the Risk Management SOP (QMS-SOP-0013), and shall include: Scope of the plan, identifying and describing the product and life cycle phases for which the plan is applicable; Allocation of responsibilities; Requirements for review of risk management activities; and Criteria for risk acceptability Conclusion regarding the results of the hazard analysis and risk management activities Refer to the Risk Management Plan and Report Template (CLR-PLN-0002). Document# QMS-SOP-007 6.3 Usability Engineering Plan The Usability Engineering Plan is developed in accordance with the Usability Engineering SOP (QMS-SOP-0011), and shall include: Scope of the plan, identifying and describing the product and life cycle phases for which the plan is applicable; Content of the usability engineering file Summary of usability verification and validation activities and results Criteria for risk acceptability for usability features Conclusion regarding the results of the risk assessment for usability features Refer to the Usability Engineering Plan and Report Template. 6.4 Design History File The Design History File contains or references the location of the documents and records necessary to demonstrate that the design was developed in accordance with this procedure and meets the regulatory requirements. Design History File documents and records are collected as development progresses through the development phases. All design history file documents are approved and released prior to transition to production phase. 7 Process Monitoring 7.1 Product Phase Status The Project Manager or Product Manager shall report on the status of Product Development at regularly scheduled reviews with Management. Status shall include current phase, expected date of review for transition to the next phase, and status of any outstanding issues surfaced at the prior phase gate review. 7.2 Documentation QA-RA shall conduct regular evaluation of the status of product documentation, identifying any elements not aligned with this SOP or the Product Development Plan for the given product. Document# QMS-SOP-007 Results of reviews and status of documentation shall be communicated to Management and reviewed at each regularly scheduled QMS Management Review meeting. 8 Quality Records Record type Description Checklist forms for the relevant phase transition shall be Phase Transition completed to document the phase deliverables for the project and Checklists to approve the transition decision. Document# QMS-SOP-007