# FormlyAI Documentation

## Docs

- [Integrations](https://docs.formly.ai/assistant/integrations.md): Learn how to connect built-in integrations and custom MCP servers so the assistant can use them when you need them.
- [Overview](https://docs.formly.ai/assistant/overview.md): The Assistant provides AI-powered help for managing your **post-certification** regulatory requirements.
- [App](https://docs.formly.ai/changelog/release-notes-webapp.md): Follow along with the latest updates and improvements to FormlyAI.
- [Approvals](https://docs.formly.ai/eqms/approvals.md): Understand the document approval process to secure compliance with all regulations.
- [Edit](https://docs.formly.ai/eqms/edit-document.md): Learn how to edit documents in FormlyAI's eQMS using the wizard or raw edit.
- [Explorer](https://docs.formly.ai/eqms/explorer.md): Navigate your medical device documentation with the Explorer.
- [Export](https://docs.formly.ai/eqms/export.md): Learn how to extract documents from your FormlyAI eQMS for external use.
- [Overview](https://docs.formly.ai/eqms/overview.md): FormlyAI's electronic Quality Management System (eQMS) for flawless medical device documentation.
- [Records](https://docs.formly.ai/eqms/records.md): Document and manage compliance records for medical device certification in FormlyAI's eQMS.
- [Revisions](https://docs.formly.ai/eqms/revisions.md): Document revisions allow you to maintain an audit trail of changes in your documentation.
- [MCP Server](https://docs.formly.ai/formly-for-ai/mcp-server.md): Connect external AI assistants to your Formly workspace using the Formly MCP Server.
- [Create Device](https://docs.formly.ai/getting-started/create-a-device.md): Learn how to add your medical device to FormlyAI using AI-powered import or manual setup for regulatory compliance.
- [FAQ](https://docs.formly.ai/getting-started/faq.md): Answers to frequently asked questions about FormlyAI's medical device certification platform, regulatory pathways, and features.
- [Introduction](https://docs.formly.ai/getting-started/introduction.md): FormlyAI is the all-in-one platform for medical device certification, regulatory compliance, and quality management systems.
- [Migration](https://docs.formly.ai/getting-started/migration.md): Seamlessly migrate your existing medical device documentation to FormlyAI with expert guidance and comprehensive planning.
- [Introduction](https://docs.formly.ai/guides/introduction.md): Learn about high level strategy to get your medical products approved in the US or EU.
- [Website & Marketing Compliance](https://docs.formly.ai/guides/webiste-and-marketing.md): Learn about the compliance requirements for your medical device's website and marketing materials.
- [Billing](https://docs.formly.ai/organization/billing.md): Manage your FormlyAI billing and payment information including invoice access and payment method updates for subscriptions.
- [Manage Organization](https://docs.formly.ai/organization/manage.md): Configure your organization name, members, and functional groups.
- [User Settings](https://docs.formly.ai/organization/user-settings.md): Manage your profile, integrations, and notification email preferences.
- [Overview](https://docs.formly.ai/regulatory-requirements/audits-and-review.md): Implement systematic audit programs and management reviews ensuring quality system effectiveness and regulatory compliance.
- [CAPAs and Vigilance](https://docs.formly.ai/regulatory-requirements/capas-vigilance.md): Integrate systematic problem resolution with proactive safety communication and incident management.
- [Clinical Evaluation](https://docs.formly.ai/regulatory-requirements/clinical-evaluation.md): Systematically evaluate clinical evidence demonstrating device safety and performance for regulatory approval.
- [Complaints](https://docs.formly.ai/regulatory-requirements/complaints.md): Establish systematic customer feedback management enabling quality improvement and regulatory compliance.
- [Overview](https://docs.formly.ai/regulatory-requirements/computer-system-validation.md): Validate computer systems ensuring software reliability and data integrity for quality management and regulatory compliance.
- [Declaration of Conformity](https://docs.formly.ai/regulatory-requirements/declaration-of-conformity.md): Issue formal legal declaration certifying device compliance with EU requirements for market authorization.
- [Deployment](https://docs.formly.ai/regulatory-requirements/deployment.md): Manage software deployment risks ensuring safe operation in customer environments throughout lifecycle.
- [Design](https://docs.formly.ai/regulatory-requirements/design.md): Transform requirements into implementable solutions defining architecture, components and technical specifications.
- [Overview](https://docs.formly.ai/regulatory-requirements/design-and-development-plans.md): Establish systematic development frameworks ensuring regulatory compliance and traceability throughout product lifecycles.
- [Design Stage Checklists](https://docs.formly.ai/regulatory-requirements/design-stage-checklists.md): Conduct systematic design reviews ensuring completeness and regulatory compliance before verification activities.
- [Overview](https://docs.formly.ai/regulatory-requirements/device-characteristics-and-classification.md): Define device characteristics and determine regulatory classification establishing your certification strategy and pathway.
- [Overview](https://docs.formly.ai/regulatory-requirements/establish-quality-management-system.md): Implement comprehensive quality management systems that ensure regulatory compliance and operational excellence for medical devices.
- [FDA Registration](https://docs.formly.ai/regulatory-requirements/fda-registration.md): Complete establishment registration and device listing establishing legal FDA presence for US market.
- [FDA Submission](https://docs.formly.ai/regulatory-requirements/fda-submission.md): Prepare comprehensive premarket submissions demonstrating safety and effectiveness for FDA clearance.
- [General Safety and Performance Requirements Checklist](https://docs.formly.ai/regulatory-requirements/general-safety-performance-requirements-checklist.md): Systematically evaluate device compliance with essential safety and performance requirements.
- [Introduction](https://docs.formly.ai/regulatory-requirements/introduction.md): Comprehensive introduction into the world of medical device regulatory requirements.
- [Labeling, Instructions for Use, and Manuals](https://docs.formly.ai/regulatory-requirements/labeling-instructions-manuals.md): Create comprehensive user documentation ensuring safe device operation and regulatory compliance.
- [Manufacturing](https://docs.formly.ai/regulatory-requirements/manufacturing.md): Validate manufacturing processes ensuring consistent production of devices meeting safety and quality requirements.
- [Medical Device File](https://docs.formly.ai/regulatory-requirements/medical-device-file.md): Compile comprehensive technical documentation supporting device safety and regulatory compliance throughout lifecycle.
- [Performance Evaluation](https://docs.formly.ai/regulatory-requirements/performance-evaluation.md): Evaluate technical performance characteristics ensuring devices meet specifications and user requirements.
- [Post-Market Surveillance](https://docs.formly.ai/regulatory-requirements/post-market-surveillance.md): Monitor device safety and performance after market release through systematic data collection and analysis.
- [Product Changes](https://docs.formly.ai/regulatory-requirements/product-changes.md): Manage systematic device modifications ensuring controlled evolution and regulatory compliance.
- [Product Release](https://docs.formly.ai/regulatory-requirements/product-release.md): Verify regulatory documentation and processes ensuring complete compliance before commercial deployment.
- [Product Requirements](https://docs.formly.ai/regulatory-requirements/product-requirements.md): Transform user needs into testable technical specifications bridging expectations with implementable design criteria.
- [Overview](https://docs.formly.ai/regulatory-requirements/purchasing,-sales-and-suppliers.md): Control supply chain quality through systematic supplier evaluation, qualification, and ongoing performance monitoring.
- [Risk Management](https://docs.formly.ai/regulatory-requirements/risk-management.md): Identify analyze and control potential hazards ensuring patient safety through systematic risk mitigation strategies.
- [Surveillance Reports](https://docs.formly.ai/regulatory-requirements/surveillance-reports.md): Document systematic device monitoring providing regulatory evidence of ongoing safety analysis.
- [Technical File](https://docs.formly.ai/regulatory-requirements/technical-file.md): Compile comprehensive technical documentation demonstrating compliance with EU regulatory requirements.
- [Overview](https://docs.formly.ai/regulatory-requirements/training.md): Develop systematic training programs ensuring personnel competency and regulatory compliance across all medical device roles.
- [UDI Creation and EUDAMED Registration](https://docs.formly.ai/regulatory-requirements/udi-eudamed-registration.md): Create unique device identifiers and register in EUDAMED database for EU market traceability.
- [Usability and Human Factors Engineering](https://docs.formly.ai/regulatory-requirements/usability-human-factors-engineering.md): Evaluate user interactions identifying and mitigating use-related risks through systematic human factors testing.
- [User Needs](https://docs.formly.ai/regulatory-requirements/user-needs.md): Capture comprehensive user expectations driving design decisions and establishing validation foundations for device development.
- [Overview](https://docs.formly.ai/regulatory-requirements/verification-validation-planning.md): Create comprehensive testing roadmap proving device meets specifications and fulfills intended medical purpose.
- [Overview](https://docs.formly.ai/regulatory-requirements/verification-validation-reports.md): Document testing results and evidence demonstrating device safety and regulatory compliance.
- [Verification and Validation Stage Checklists](https://docs.formly.ai/regulatory-requirements/verification-validation-stage-checklists.md): Review testing completeness and readiness for regulatory submission through systematic checklists.
- [Overview](https://docs.formly.ai/roadmap/overview.md): Navigate your medical device regulatory journey with FormlyAI's roadmap covering QMS, design, development, and submission.
- [Tasks](https://docs.formly.ai/roadmap/tasks.md): Understand FormlyAI's task management system for medical device documentation with states, dependencies, and workflow tracking.
- [Additional Software Test Plans](https://docs.formly.ai/tasks/additional-software-test-plans.md): Create specialized testing strategies addressing cybersecurity, performance, and integration requirements.
- [Additional Software Test Reports](https://docs.formly.ai/tasks/additional-software-test-reports.md): Document specialized testing results covering cybersecurity, performance, and integration verification.
- [Audit Plan](https://docs.formly.ai/tasks/audit-plan.md): Plan systematic audit activities defining scope, objectives, timing, and logistics for quality system evaluation.
- [Audit Program](https://docs.formly.ai/tasks/audit-program.md): Schedule comprehensive audit coverage across multiple years ensuring systematic quality management system verification.
- [Audit Report](https://docs.formly.ai/tasks/audit-report.md): Document audit findings and corrective actions providing objective evidence of quality system performance.
- [Biocompatibility Evaluation Report](https://docs.formly.ai/tasks/biocompatibility-evaluation-report.md): Document biological safety assessment demonstrating material compatibility and patient protection.
- [Biological Evaluation Plan](https://docs.formly.ai/tasks/biological-evaluation-plan.md): Develop biocompatibility testing strategy ensuring patient-contact materials meet safety standards.
- [Bug Fix Report Template](https://docs.formly.ai/tasks/bug-fix-report.md): Document systematic software defect resolution ensuring regulatory compliance and patient safety.
- [CAPA Plan](https://docs.formly.ai/tasks/capa-plan.md): Plan systematic corrective and preventive actions addressing quality issues and root causes.
- [CAPA Report](https://docs.formly.ai/tasks/capa-report.md): Document CAPA execution and effectiveness verification proving successful problem resolution.
- [Change Evaluation Report](https://docs.formly.ai/tasks/change-evaluation-report.md): Assess implemented changes determining regulatory significance and required compliance actions.
- [Change Request](https://docs.formly.ai/tasks/change-request.md): Initiate controlled device modifications through systematic evaluation and approval processes.
- [Checklist Software Release](https://docs.formly.ai/tasks/checklist-software-release.md): Verify documentation completeness and process compliance before releasing medical device software versions.
- [Clinical Evaluation Plan](https://docs.formly.ai/tasks/clinical-evaluation-plan.md): Establish systematic approach demonstrating device safety and clinical performance through evidence analysis.
- [Clinical Evaluation Report](https://docs.formly.ai/tasks/clinical-evaluation-report.md): Document systematic clinical evidence analysis supporting regulatory approval and market compliance.
- [Clinical Investigations Consult with FormlyAI](https://docs.formly.ai/tasks/clinical-investigations-consult-with-formlyai.md): Receive expert guidance determining clinical study needs and designing efficient investigation protocols.
- [Complaint Log](https://docs.formly.ai/tasks/complaint-log.md): Track customer complaints systematically enabling trend analysis and quality improvement.
- [EU Declaration Of Conformity](https://docs.formly.ai/tasks/declaration-of-conformity.md): Issue formal legal statement declaring device compliance with EU regulatory requirements for CE marking.
- [Deployment Evaluation Checklist](https://docs.formly.ai/tasks/deployment-evaluation-checklist.md): Assess deployment complexity and risks ensuring safe software operation in customer environments.
- [Design History File](https://docs.formly.ai/tasks/design-history-file.md): Compile comprehensive design control records demonstrating systematic development and regulatory compliance.
- [Design Review Checklist](https://docs.formly.ai/tasks/design-review-checklist.md): Verify design completeness and readiness for verification through systematic review criteria and evaluation.
- [Design Transfer Plan](https://docs.formly.ai/tasks/design-transfer-plan.md): Establish systematic approach for transferring validated design to manufacturing ensuring production accuracy.
- [Design Transfer Report](https://docs.formly.ai/tasks/design-transfer-report.md): Document successful design transfer completion proving manufacturing capability and regulatory readiness.
- [Device Label](https://docs.formly.ai/tasks/device-label.md): Create regulatory-compliant device identification displaying required safety and regulatory markings.
- [Electrical Design](https://docs.formly.ai/tasks/electrical-design.md): Specify electronic components, circuits and electrical safety measures for reliable device performance.
- [Electrical Verification Protocol](https://docs.formly.ai/tasks/electrical-verification-protocol.md): Execute systematic electrical safety testing ensuring IEC 60601 compliance and patient protection.
- [Electrical Verification Report](https://docs.formly.ai/tasks/electrical-verification-report.md): Document electrical safety testing results proving IEC compliance and hazard protection.
- [FDA 510(k) ESTAR](https://docs.formly.ai/tasks/fda-510k-estar.md): Prepare electronic submission demonstrating substantial equivalence for FDA clearance and market authorization.
- [FDA Device Classification](https://docs.formly.ai/tasks/fda-device-classification.md): Determine product code and regulatory pathway through intended use analysis and classification database research.
- [FDA Predicate Device](https://docs.formly.ai/tasks/fda-predicate-device.md): Identify appropriate predicate devices establishing substantial equivalence foundation for successful clearance submissions.
- [FDA Registration And Listing](https://docs.formly.ai/tasks/fda-registration-and-listing.md): Register establishment and list devices with FDA establishing legal presence for US market access.
- [Field Safety Notice Form](https://docs.formly.ai/tasks/field-safety-notice.md): Communicate urgent safety information to users requiring immediate protective actions.
- [Firmware Design](https://docs.formly.ai/tasks/firmware-design.md): Develop low-level software controlling hardware components with real-time requirements and safety measures.
- [GSPR Checklist](https://docs.formly.ai/tasks/gspr-checklist.md): Systematically evaluate compliance with essential safety and performance requirements for EU market access.
- [Hardware Design and Development Plan](https://docs.formly.ai/tasks/hardware-design-and-development-plan.md): Design physical device components through systematic development phases ensuring safety and regulatory compliance.
- [Incident Assessment Form](https://docs.formly.ai/tasks/incident-assessment-form.md): Evaluate device incidents systematically determining regulatory reporting requirements and actions.
- [Instructions For Use](https://docs.formly.ai/tasks/instructions-for-use.md): Provide comprehensive guidance ensuring safe effective device operation with regulatory compliance.
- [Intended Use](https://docs.formly.ai/tasks/intended-use.md): Define precise medical purpose and application scope determining regulatory classification and testing requirements.
- [Interface Design](https://docs.formly.ai/tasks/interface-design.md): Design user interactions and system communications ensuring safety and effective device operation.
- [IVDR Device Classification](https://docs.formly.ai/tasks/ivdr-device-classification.md): Classify in vitro diagnostic devices based on clinical significance and patient impact for proper conformity assessment.
- [List of CAPAs](https://docs.formly.ai/tasks/list-capa.md): Maintain centralized register enabling CAPA trend analysis and management oversight activities.
- [List Of Known Anomalies](https://docs.formly.ai/tasks/list-of-known-anomalies.md): Document residual software bugs ensuring transparent risk assessment and informed release decisions.
- [List Of Medical Devices](https://docs.formly.ai/tasks/list-of-medical-devices.md): Maintain comprehensive registry tracking all device versions and market availability throughout lifecycle.
- [Approved Supplier List](https://docs.formly.ai/tasks/list-of-qualified-suppliers.md): Maintain qualified supplier registry with performance tracking and risk-based monitoring for supply chain assurance.
- [List Of Regulatory Requirements](https://docs.formly.ai/tasks/list-of-regulatory-requirements.md): Track applicable regulations and standards ensuring comprehensive compliance coverage across all target markets.
- [List of Validated Software](https://docs.formly.ai/tasks/list-of-validated-software.md): Maintain centralized registry of validated software systems with deployment status and ongoing review schedules.
- [Management Review Report](https://docs.formly.ai/tasks/management-review-report.md): Evaluate quality system effectiveness through executive assessment and strategic planning for continuous improvement.
- [Manufacturing Validation Plan and Protocol](https://docs.formly.ai/tasks/manufacturing-validation-plan-and-protocol.md): Establish systematic procedures proving manufacturing processes produce consistent, compliant devices.
- [Manufacturing Validation Report](https://docs.formly.ai/tasks/manufacturing-validation-report.md): Document manufacturing process validation results demonstrating production capability and control.
- [Marketing Content](https://docs.formly.ai/tasks/marketing-content.md): Develop regulatory-compliant promotional materials communicating device benefits while maintaining accuracy.
- [MDR Device Classification](https://docs.formly.ai/tasks/mdr-device-classification.md): Determine device risk class through systematic rule application ensuring proper conformity assessment procedures.
- [Mechanical Design](https://docs.formly.ai/tasks/mechanical-design.md): Define physical structure, materials and mechanical specifications ensuring safety and biocompatibility.
- [Other Languages Translated IFUs](https://docs.formly.ai/tasks/other-languages-translated-ifus.md): Develop additional language versions ensuring consistent safety information across global markets.
- [Packaging and Shelf Life Design](https://docs.formly.ai/tasks/packaging-and-shelf-life-design.md): Design protective packaging systems and validate shelf life ensuring product integrity and sterility.
- [Packaging And Shelf-Life Verification Protocol](https://docs.formly.ai/tasks/packaging-and-shelf-life-verification-protocol.md): Implement detailed testing procedures validating packaging integrity and device stability claims.
- [Packaging and Shelf-Life Verification Report](https://docs.formly.ai/tasks/packaging-and-shelf-life-verification-report.md): Document packaging integrity testing validating stability claims and storage requirements.
- [Performance and Bench Verification and Validation Report](https://docs.formly.ai/tasks/performance-and-bench-verification-and-validation-report.md): Document laboratory testing results demonstrating device performance specifications and safety compliance.
- [Performance and Bench Verification Guide](https://docs.formly.ai/tasks/performance-and-bench-verification-guide.md): Plan systematic laboratory testing framework verifying device specifications and validating user needs.
- [Performance And Bench Verification Protocol](https://docs.formly.ai/tasks/performance-and-bench-verification-protocol.md): Execute detailed testing procedures ensuring reproducible performance verification and validation results.
- [Periodic Safety Update Report](https://docs.formly.ai/tasks/periodic-safety-update-report.md): Provide comprehensive benefit-risk analysis supporting continued device market authorization.
- [Physician's Handbook](https://docs.formly.ai/tasks/physicians-handbook.md): Create specialized clinical reference supporting healthcare providers with professional implementation guidance.
- [Post-Market Clinical Follow-up Plan](https://docs.formly.ai/tasks/post-market-clinical-follow-up-plan.md): Define clinical data collection strategy addressing evidence gaps and confirming real-world performance.
- [Post-Market Clinical Follow-Up Report](https://docs.formly.ai/tasks/post-market-clinical-follow-up-report.md): Document real-world clinical evidence validating continued device safety and effectiveness.
- [Post-Market Surveillance Plan](https://docs.formly.ai/tasks/post-market-surveillance-plan.md): Establish systematic monitoring approach ensuring ongoing device safety and regulatory compliance.
- [Post-Market Surveillance Report](https://docs.formly.ai/tasks/post-market-surveillance-report.md): Analyze systematic safety data demonstrating ongoing device monitoring and risk assessment.
- [Primary Language Translated IFU](https://docs.formly.ai/tasks/primary-language-translated-ifu.md): Create master language translation maintaining regulatory accuracy and cultural appropriateness.
- [Quality Manual, Policy & Objectives](https://docs.formly.ai/tasks/quality-manual-policy-objectives.md): Develop quality policy foundations and measurable objectives that guide QMS effectiveness and regulatory compliance.
- [Release Notes](https://docs.formly.ai/tasks/release-notes.md): Document software changes and improvements communicating updates to users and regulatory authorities.
- [Required Documentation Training by Functional Group](https://docs.formly.ai/tasks/required-documentation-training-by-functional-group.md): Assign role-specific training requirements through systematic functional group matrices ensuring relevant competency development.
- [Risk Assessment](https://docs.formly.ai/tasks/risk-assessment.md): Systematically identify analyze and evaluate device hazards establishing foundation for targeted risk control measures.
- [Risk Management Plan](https://docs.formly.ai/tasks/risk-management-plan.md): Establish systematic risk management framework defining acceptance criteria responsibilities and lifecycle processes.
- [Risk Management Report](https://docs.formly.ai/tasks/risk-management-report.md): Summarize risk management activities demonstrating successful hazard control and regulatory compliance achievement.
- [Shelf Life Verification Guide](https://docs.formly.ai/tasks/shelf-life-verification-guide.md): Plan systematic aging studies validating device stability and performance throughout storage periods.
- [Software Architecture](https://docs.formly.ai/tasks/software-architecture.md): Define software structure, organization and components following safety classification and development standards.
- [Software Development and Maintenance Plan](https://docs.formly.ai/tasks/software-development-and-maintenance-plan.md): Structure comprehensive software lifecycle processes ensuring safety classification compliance and systematic development.
- [Software System Test Plan](https://docs.formly.ai/tasks/software-system-test-plan.md): Define comprehensive software testing approach verifying requirements and ensuring regulatory compliance.
- [Software System Test Report](https://docs.formly.ai/tasks/software-system-test-report.md): Document software testing execution proving requirements compliance and regulatory readiness.
- [Software Validation Form](https://docs.formly.ai/tasks/software-validation-form.md): Document systematic software validation through risk assessment, testing, and compliance verification processes.
- [SOP Corrective and Preventive Action (CAPA)](https://docs.formly.ai/tasks/sop-capa.md): Investigate and resolve quality issues through systematic root cause analysis and proportionate corrective actions.
- [SOP Change Management](https://docs.formly.ai/tasks/sop-change-management.md): Evaluate and implement device modifications through systematic risk assessment and regulatory compliance procedures.
- [SOP Clinical Evaluation](https://docs.formly.ai/tasks/sop-clinical-evaluation.md): Generate clinical evidence demonstrating device safety and effectiveness through systematic evaluation and literature review.
- [SOP Cybersecurity](https://docs.formly.ai/tasks/sop-cybersecurity.md): Implement comprehensive cybersecurity frameworks protecting medical devices from cyber threats throughout device lifecycles.
- [SOP Deployment](https://docs.formly.ai/tasks/sop-deployment.md): Coordinate controlled deployment processes for medical device software installation, integration, and monitoring.
- [SOP Design Control](https://docs.formly.ai/tasks/sop-design-control.md): Deploy systematic design control frameworks for safe and effective medical device development from concept to market.
- [SOP Document and Record Control](https://docs.formly.ai/tasks/sop-document-record-control.md): Structure systematic document control procedures for quality management system compliance and information integrity.
- [SOP Feedback and Complaint Management](https://docs.formly.ai/tasks/sop-feedback-management.md): Handle customer feedback and complaints through systematic investigation, resolution, and corrective action processes.
- [SOP Human Resources and Training](https://docs.formly.ai/tasks/sop-human-resources-administration.md): Organize comprehensive HR frameworks for personnel qualification, training documentation, and competency verification.
- [SOP Software Development](https://docs.formly.ai/tasks/sop-integrated-software-development.md): Integrate software development lifecycles ensuring medical device safety and regulatory compliance.
- [SOP Internal Audit](https://docs.formly.ai/tasks/sop-internal-audit.md): Audit quality management systems through independent evaluation ensuring regulatory compliance and continuous improvement.
- [SOP Management Review](https://docs.formly.ai/tasks/sop-management-review.md): Build effective management review procedures to assess your QMS, to ensure quality outcomes.
- [SOP Manufacturing](https://docs.formly.ai/tasks/sop-manufacturing.md): Control systematic manufacturing processes ensuring design transfer, production quality, and regulatory compliance.
- [SOP Nonconformance](https://docs.formly.ai/tasks/sop-nonconformance.md): Control procedures for identifying, evaluating, and managing nonconforming products and processes in medical device QMS.
- [SOP Performance Evaluation](https://docs.formly.ai/tasks/sop-performance-evaluation.md): Demonstrate IVD device performance through scientific validity, analytical testing, and clinical performance evaluation.
- [SOP Post-Market Surveillance](https://docs.formly.ai/tasks/sop-post-market-surveillance.md): Monitor real-world device performance through systematic data collection, analysis, and regulatory compliance reporting.
- [SOP Product Registration and Certification](https://docs.formly.ai/tasks/sop-product-registration-and-certification.md): Navigate regulatory approval processes from technical file creation through market authorization and UDI registration.
- [SOP Purchasing](https://docs.formly.ai/tasks/sop-purchasing.md): Qualify and manage suppliers ensuring purchased products meet quality requirements and regulatory standards.
- [SOP Risk Management](https://docs.formly.ai/tasks/sop-risk-management.md): Manage systematic risk identification, analysis, and control processes ensuring patient safety and regulatory compliance.
- [SOP Sales](https://docs.formly.ai/tasks/sop-sales.md): Market medical devices through controlled processes ensuring validated claims and compliant distribution channels.
- [SOP Software Problem Resolution](https://docs.formly.ai/tasks/sop-software-problem-resolution.md): Execute systematic frameworks for identifying, investigating, and resolving software problems throughout device lifecycles.
- [SOP Software Validation](https://docs.formly.ai/tasks/sop-software-validation.md): Validate computer system processes ensuring software reliability and compliance throughout lifecycles.
- [SOP Statistical Methods](https://docs.formly.ai/tasks/sop-statistical-methods.md): Apply statistical analysis guidelines for medical device verification, validation, and regulatory compliance testing.
- [SOP Regulatory Strategy](https://docs.formly.ai/tasks/sop-update-of-regulations.md): Track regulatory changes and develop strategic approaches ensuring continuous compliance across jurisdictions.
- [SOP Usability Engineering](https://docs.formly.ai/tasks/sop-usability-engineering.md): Design systematic usability processes to prevent use errors and ensure patient safety through human factors engineering.
- [SOP Vigilance](https://docs.formly.ai/tasks/sop-vigilance.md): Report serious incidents and safety events to regulatory authorities through systematic vigilance and field corrective action procedures.
- [SOUP List](https://docs.formly.ai/tasks/soup-list.md): Document third-party software components with risk assessments ensuring safe integration and regulatory compliance.
- [Subsystem Requirements List](https://docs.formly.ai/tasks/subsystem-requirements-list.md): Break down system specifications into detailed implementable requirements for individual device components and subsystems.
- [Supplier Checklist](https://docs.formly.ai/tasks/supplier-checklist.md): Evaluate supplier capabilities through systematic assessment criteria ensuring quality system compliance and performance.
- [System Requirements List](https://docs.formly.ai/tasks/system-requirements-list.md): Translate user needs into objective testable requirements defining device functionality and performance criteria.
- [Technical File](https://docs.formly.ai/tasks/technical-file.md): Compile comprehensive documentation package demonstrating device compliance with requirements for CE marking.
- [Traceability Matrix](https://docs.formly.ai/tasks/traceability-matrix.md): Map user needs through requirements to testing ensuring complete coverage and regulatory compliance.
- [Training Log](https://docs.formly.ai/tasks/training-log.md): Track individual employee training completion and competency development through systematic documentation and records.
- [UDI Creation](https://docs.formly.ai/tasks/udi-creation.md): Establish unique device identification enabling complete traceability and regulatory compliance.
- [Usability Evaluation Plan](https://docs.formly.ai/tasks/usability-evaluation-plan.md): Design systematic user testing strategy to identify interface risks and ensure safe device operation.
- [Usability Evaluation Protocol](https://docs.formly.ai/tasks/usability-evaluation-protocol.md): Execute detailed user testing procedures validating safe interface operation and error prevention.
- [Usability Evaluation Report](https://docs.formly.ai/tasks/usability-evaluation-report.md): Document user testing results proving interface safety and regulatory compliance achievement.
- [User Manual](https://docs.formly.ai/tasks/user-manual.md): Create comprehensive operational guide maximizing device functionality and user experience.
- [User Needs List](https://docs.formly.ai/tasks/user-needs-list.md): Document user expectations providing design compass and regulatory foundation through solution-neutral requirement capture.
- [Verification and Validation Plan](https://docs.formly.ai/tasks/verification-and-validation-plan.md): Establish comprehensive testing strategy proving device correctness and suitability for intended medical use.
- [Verification And Validation Report](https://docs.formly.ai/tasks/verification-and-validation-report.md): Summarize comprehensive testing activities proving device safety effectiveness and market readiness.
- [Overview](https://docs.formly.ai/todo/overview.md): Stay on top of your tasks with FormlyAI's Todo system.
- [Integrations and MCP Connections](https://docs.formly.ai/user-settings/integrations-and-mcp-connections.md): How to connect integrations and add MCP servers.
- [Lists](https://docs.formly.ai/wizard/lists.md): How to edit lists in the wizard.
- [Overview](https://docs.formly.ai/wizard/overview.md): The wizard guides you through each document and offers automatically generated suggestions.
- [Tables](https://docs.formly.ai/wizard/tables.md): If your task requires a table (e.g. Risk Assessment Table) the wizard will create a table with the required inputs.

## Optional

- [Website](https://formly.ai)
- [Support](https://app.formly.ai)
- [Blog](https://blog.formly.ai)