Designed for organizations that maintain an existing Quality Management System and need targeted, audit-ready reinforcement across software lifecycle, risk management, design controls, and cybersecurity, without rebuilding your core system.
This structured add-on integrates directly into your ISO 13485 QMS framework, closing documentation gaps across IEC 62304, ISO 14971, and FDA cybersecurity guidance requirements. Every deliverable is scoped to strengthen traceability, risk alignment, and regulator readiness from day one.
Includes two 45-minute calls — onboarding and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 10 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.
SECTION 1: 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 2: 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 3: 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 4: 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 2025 Cybersecurity in Medical Devices guidance and EU MDR/IVDR expectations for networked and software-based devices.
SECTION 5: 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 add-on is built for SaMD developers, medical device manufacturers, and regulatory teams who need a defensible, submission-ready software documentation system — and don't have time to build it from scratch. It's equally suited to companies preparing for a first FDA submission, closing a notified body audit finding, or formalizing a QMS ahead of a Series A or strategic partnership.
What's Not Included
This product does not include quality manual development, full QMS build-out, regulatory strategy consulting, or submission support. If your needs extend beyond documentation, contact us for something that may be a better fit.
Designed for organizations that maintain an existing Quality Management System and need targeted, audit-ready reinforcement across software lifecycle, risk management, design controls, and cybersecurity, without rebuilding your core system.
This structured add-on integrates directly into your ISO 13485 QMS framework, closing documentation gaps across IEC 62304, ISO 14971, and FDA cybersecurity guidance requirements. Every deliverable is scoped to strengthen traceability, risk alignment, and regulator readiness from day one.
Includes two 45-minute calls — onboarding and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 10 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.
SECTION 1: 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 2: 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 3: 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 4: 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 2025 Cybersecurity in Medical Devices guidance and EU MDR/IVDR expectations for networked and software-based devices.
SECTION 5: 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 add-on is built for SaMD developers, medical device manufacturers, and regulatory teams who need a defensible, submission-ready software documentation system — and don't have time to build it from scratch. It's equally suited to companies preparing for a first FDA submission, closing a notified body audit finding, or formalizing a QMS ahead of a Series A or strategic partnership.
What's Not Included
This product does not include quality manual development, full QMS build-out, regulatory strategy consulting, or submission support. If your needs extend beyond documentation, contact us for something that may be a better fit.
