Image 1 of 1
Full QMS System (ISO 13485 + IEC 62304 + Cybersecurity)
Designed for organizations building connected or networked Software as a Medical Device who need a complete, submission-ready compliance infrastructure — built to the highest regulatory standard in a single integrated system.
This flagship system combines ISO 13485 quality management, IEC 62304 software lifecycle controls, and FDA-aligned cybersecurity documentation into one cohesive framework. Every section is structured for traceability, risk alignment, and regulator readiness — whether you're targeting FDA premarket submission, EU MDR conformity, or notified body certification.
Includes four 45-minute calls — onboarding, two mid-point check-ins, and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 20 Business Days from onboarding call.
Deliverable Format All documents delivered as fully editable Word files in a structured folder architecture with numbered document hierarchy and implementation guidance notes embedded throughout.
This integrated system delivers structured documents and templates across quality management, software lifecycle control, cybersecurity compliance, and risk-based validation.
SECTION 1: Quality Management System (ISO 13485)
Governance Quality Manual · QMS Scope Statement · Quality Policy · Quality Objectives Template · Organizational Responsibility Matrix
Document & Record Control Document Control Procedure · Record Control Procedure · Change Control Procedure · Master Document List · Document Change Log · Controlled Form Template
Management Responsibility Management Review Procedure · Management Review Agenda Template · Management Review Minutes Template · Management Review Action Log
Internal Audit Internal Audit Procedure · Audit Schedule Template · Audit Checklist (General) · Audit Report Template
CAPA & Nonconformance CAPA Procedure · CAPA Form · Nonconforming Product Procedure · Nonconformance Report Template · Root Cause Analysis Template · Corrective Action Plan Template
Supplier Controls Supplier Evaluation Procedure · Supplier Qualification Form · Approved Supplier List · Supplier Monitoring Log · Purchasing Controls Procedure · Supplier Agreement Template
Training & Competency Training Procedure · Training Record Template · Training Matrix · Competency Evaluation Form
Post-Market & Feedback Complaint Handling Procedure · Complaint Record Template · Feedback Handling Procedure · Advisory Notice Template · Post-Market Surveillance Plan
SECTION 2: IEC 62304 Software Lifecycle
Lifecycle Planning Software Development Plan · Software Safety Classification Framework · Software Configuration Management Plan · Software Maintenance Plan · Software Problem Resolution Procedure · Software Release Plan
Requirements & Architecture Software Requirements Specification · System Requirements Specification · Architecture Description Template · Detailed Design Template · Interface Specification Template · Requirements Change Log · Requirements Review Record · Software Requirements Trace Log
Risk Management (ISO 14971 Aligned) Risk Management Procedure · Software Risk Management Plan · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk Evaluation Form · Residual Risk Evaluation Template · Risk Review Meeting Record
Verification & Validation Verification & Validation Master Plan · Unit Test Protocol Template · Unit Test Report Template · Integration Test Protocol · Integration Test Report · System Test Protocol · System Test Report · User Acceptance Test Plan · UAT Report Template · Verification Summary Report
Configuration & Change Management Configuration Identification Log · Configuration Change Request Form · Software Baseline Record · Version Control Log · Build Release Record · Change Impact Assessment Template
SECTION 3: Integrated Design Controls Design & Development Procedure · Design and Development Plan · Design Input Template · Design Output Template · Design Review Record · Design Verification Plan · Design Validation Plan · Design Transfer Record
SECTION 4: Traceability & DHF End-to-End Traceability Matrix · Risk-to-Control Mapping Matrix · Requirements-to-Test Coverage Matrix · DHF Index Template · Technical File Index Template · Submission Readiness Checklist
SECTION 5: Cybersecurity Compliance Cybersecurity Risk Management Procedure · Threat Modeling Template (STRIDE) · Software Bill of Materials (SBOM) Template · Security Requirements Specification · Vulnerability Management Procedure · Incident Response Plan · Cybersecurity Testing Protocol Template
Aligned to FDA's 2023 Cybersecurity in Medical Devices guidance and EU MDR/IVDR expectations for networked and software-based devices.
SECTION 6: Implementation Acceleration Tools AI Documentation Prompt Library · AI-Assisted Gap Analysis Prompts · Document Review Checklist Library · 30-60-90 Day Implementation Roadmap
Purpose-built tools to accelerate document population, close gaps faster, and keep your team aligned through each phase of implementation.
Who This Is For
This system is built for SaMD developers and digital health teams building connected, networked, or cloud-based medical devices who need the most complete compliance infrastructure available in a single purchase. It's the right choice for organizations preparing for FDA premarket submission under current cybersecurity guidance, pursuing CE marking under EU MDR, or establishing enterprise-grade quality infrastructure ahead of a Series A or strategic partnership.
What's Not Included
This system does not include regulatory strategy consulting, submission support, or custom cybersecurity architecture assessment. If your needs extend beyond documentation, [link to your consulting services page] may be a better fit.
Designed for organizations building connected or networked Software as a Medical Device who need a complete, submission-ready compliance infrastructure — built to the highest regulatory standard in a single integrated system.
This flagship system combines ISO 13485 quality management, IEC 62304 software lifecycle controls, and FDA-aligned cybersecurity documentation into one cohesive framework. Every section is structured for traceability, risk alignment, and regulator readiness — whether you're targeting FDA premarket submission, EU MDR conformity, or notified body certification.
Includes four 45-minute calls — onboarding, two mid-point check-ins, and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 20 Business Days from onboarding call.
Deliverable Format All documents delivered as fully editable Word files in a structured folder architecture with numbered document hierarchy and implementation guidance notes embedded throughout.
This integrated system delivers structured documents and templates across quality management, software lifecycle control, cybersecurity compliance, and risk-based validation.
SECTION 1: Quality Management System (ISO 13485)
Governance Quality Manual · QMS Scope Statement · Quality Policy · Quality Objectives Template · Organizational Responsibility Matrix
Document & Record Control Document Control Procedure · Record Control Procedure · Change Control Procedure · Master Document List · Document Change Log · Controlled Form Template
Management Responsibility Management Review Procedure · Management Review Agenda Template · Management Review Minutes Template · Management Review Action Log
Internal Audit Internal Audit Procedure · Audit Schedule Template · Audit Checklist (General) · Audit Report Template
CAPA & Nonconformance CAPA Procedure · CAPA Form · Nonconforming Product Procedure · Nonconformance Report Template · Root Cause Analysis Template · Corrective Action Plan Template
Supplier Controls Supplier Evaluation Procedure · Supplier Qualification Form · Approved Supplier List · Supplier Monitoring Log · Purchasing Controls Procedure · Supplier Agreement Template
Training & Competency Training Procedure · Training Record Template · Training Matrix · Competency Evaluation Form
Post-Market & Feedback Complaint Handling Procedure · Complaint Record Template · Feedback Handling Procedure · Advisory Notice Template · Post-Market Surveillance Plan
SECTION 2: IEC 62304 Software Lifecycle
Lifecycle Planning Software Development Plan · Software Safety Classification Framework · Software Configuration Management Plan · Software Maintenance Plan · Software Problem Resolution Procedure · Software Release Plan
Requirements & Architecture Software Requirements Specification · System Requirements Specification · Architecture Description Template · Detailed Design Template · Interface Specification Template · Requirements Change Log · Requirements Review Record · Software Requirements Trace Log
Risk Management (ISO 14971 Aligned) Risk Management Procedure · Software Risk Management Plan · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk Evaluation Form · Residual Risk Evaluation Template · Risk Review Meeting Record
Verification & Validation Verification & Validation Master Plan · Unit Test Protocol Template · Unit Test Report Template · Integration Test Protocol · Integration Test Report · System Test Protocol · System Test Report · User Acceptance Test Plan · UAT Report Template · Verification Summary Report
Configuration & Change Management Configuration Identification Log · Configuration Change Request Form · Software Baseline Record · Version Control Log · Build Release Record · Change Impact Assessment Template
SECTION 3: Integrated Design Controls Design & Development Procedure · Design and Development Plan · Design Input Template · Design Output Template · Design Review Record · Design Verification Plan · Design Validation Plan · Design Transfer Record
SECTION 4: Traceability & DHF End-to-End Traceability Matrix · Risk-to-Control Mapping Matrix · Requirements-to-Test Coverage Matrix · DHF Index Template · Technical File Index Template · Submission Readiness Checklist
SECTION 5: Cybersecurity Compliance Cybersecurity Risk Management Procedure · Threat Modeling Template (STRIDE) · Software Bill of Materials (SBOM) Template · Security Requirements Specification · Vulnerability Management Procedure · Incident Response Plan · Cybersecurity Testing Protocol Template
Aligned to FDA's 2023 Cybersecurity in Medical Devices guidance and EU MDR/IVDR expectations for networked and software-based devices.
SECTION 6: Implementation Acceleration Tools AI Documentation Prompt Library · AI-Assisted Gap Analysis Prompts · Document Review Checklist Library · 30-60-90 Day Implementation Roadmap
Purpose-built tools to accelerate document population, close gaps faster, and keep your team aligned through each phase of implementation.
Who This Is For
This system is built for SaMD developers and digital health teams building connected, networked, or cloud-based medical devices who need the most complete compliance infrastructure available in a single purchase. It's the right choice for organizations preparing for FDA premarket submission under current cybersecurity guidance, pursuing CE marking under EU MDR, or establishing enterprise-grade quality infrastructure ahead of a Series A or strategic partnership.
What's Not Included
This system does not include regulatory strategy consulting, submission support, or custom cybersecurity architecture assessment. If your needs extend beyond documentation, [link to your consulting services page] may be a better fit.