MedTech Journey Checklist: Product Development

Curriculum

• Getting Started with the Checklist
• Project Planning
• Writing the Project Plan
• Write Marketing Plan
• Establish regulatory strategy
• Write manufacturing plan
• Write software development plan
• Establish project schedule/timeline
• Define usability plan
• Determine clinical investigation requirements
• V+V Budget Determination
• Determine reimbursement codes
• Create software architecture diagram (if applicable)
• Software safety classification (if applicable)
• Upload and approve Project Plan
• Create new Project in Greenlight Guru
• Link planning document(s)
• Create components in Greenlight Guru Project
• Prepare for design controls
• Optional Bonus Material - GG Academy Professional Courses
• Risk Management Planning
• Risk Management Plan
• Determine risk management team
• Establish risk acceptability matrix criteria
• Upload and approve Risk Management Plan
• Link Risk Management Plan
• Option Bonus Material - GG Academy Professional Course
• User Needs
• Add user needs into your design control matrix
• Document the Intended Use and Indications for Use
• Determine Usability/Human Factors needs
• Conduct market research including on predicate device(s)
• Search the MAUDE database
• Downselect user needs
• Design Review
• Optional Bonus Content
• Design Inputs
• Add design inputs into your design control matrix in GG
• Conduct market research
• Determine technical characteristics
• Functional and performance requirements
• Manufacturing requirements
• Software and cybersecurity requirements
• Review electromechanical requirements
• Obtain Biological Plan/Report
• Determine sterility requirements
• Determine material compatibility
• Perform sterility validation
• Obtain sterility certificates
• Complete dose mapping/BI testing
• Obtain testing quotes
• Obtain testing lead times
• Requirements from device specific standards
• Packaging and labeling requirements
• Risk Control measures
• Link design inputs to applicable user needs
• Link system design inputs to subsystem design inputs
• Conduct a Design Review
• Optional Bonus Material - GG Academy Professional Course: Introduction to Safety for Electrical Medical Devices and IEC 60601
• Risk Analysis
• Establish Risk Policy
• Setup the Risk Acceptability Matrix
• Identify Hazards, Foreseeable Events, Hazardous Situations, and Harms
• Identify new Design Inputs needed to mitigate the harms identified
• Search the MAUDE database
• Obtain clinician input
• Cybersecurity risk analysis (if applicable)
• Design Reviews
• Create a Design Review
• Design Review Meeting
• Document Design Review Meeting
• Approve and publish the design review
• Design Outputs
• Ensure Phase 3 of Implementation Plan is in progress
• Design the device and establish records of the design
• Upload and approve records as Documents in Greenlight Guru
• Create Design Output items in trace matrix and link to applicable Design Inputs
• Link version specific records to Design Outputs as applicable
• Create Bill of Materials (BOM)
• Order materials/prototypes etc
• Write the Verification and Validation Plan
• Conduct a Design Review
• Supplier Management
• Ensure Phase 3 of Implementation Plan is in progress
• Identify suppliers
• Plan supplier management in GG
• Complete supplier surveys
• Complete supplier evaluations
• Establish approved supplier list
• Setup purchasing procedure and purchase order form
• Identify necessary supplier audits
• Establish supplier quality agreements as needed
• Device Master Record (DMR)
• Reference Phase 4 of Implementation Plan
• Begin design transfer checklist
• Start considering manufacturing and adding applicable design outputs
• Create WIs for manufacturing
• Establish process flows for manufacturing
• Create manufacturing diagrams
• Identify incoming inspection criteria and processes
• Create cleaning checklist
• Labeling and UDI
• Determine issuing body
• Obtain UDI numbers
• Determine applicable PIs
• Determine GMDN
• Establish packaging configurations/barcode options
• Obtain artwork approval
• Obtain marketing buy-in
• Conduct First Article of Inspection
• GUDID/EUDAMED submissions
• Risk Evaluation
• Determine and assign severity and probability of harms
• Pre mitigation - prior to risk controls
• Identify the design controls that mitigate the harms
• Post mitigation - after risk controls
• Add any new design controls as needed
• Determine if any new risks have arisen from adding the controls
• Benefit Risk Analysis
• Stability/Shelf-Life
• Plan accelerated aging/Real-time
• Complete AA Testing/Real-time Aging Testing
• Equipment/Software Validation
• Ensure Phase 4 of Implementation Plan is in progress
• Obtain quotes and lead time for equipment and software tools
• Create Master Validation Plan
• Write, approve, and execute test protocols
• Compile test reports
• Design Verification
• Determine sampling plan
• Third-party testing
• In-house bench testing
• Cybersecurity testing (if applicable)
• Write, approve, and execute test protocols
• Compile test reports
• Design Validation
• Simulated use testing
• Clinical trial - see Clinical Studies section
• Usability/Human Factors study
• Write, approve, and execute test protocols
• Compile test reports
• Usability/Human Factors
• User group selection
• Identify critical tasks
• Identify use hazards and include in risk management file
• Complete formative evaluations throughout the development process
• Complete summative evaluation
• Complete User Interface of Unknown Provenance testing and/or report (if applicable)
• Clinical Studies
• Identify Scope
• Determine Cost
• Determine Sites
• Define patient population
• Establish desired outcomes (what is considered passing, etc)
• Design History File (DHF)
• Route DHF
• Approve DHF
• Create a View for DHF
• Summary
• Summary