Designed for medical device teams that need a robust, audit-ready Quality Management System built to ISO 13485 standards — without the overhead of a full software lifecycle integration.

This structured system delivers a complete documentation framework across all core ISO 13485 process domains, with risk management alignment, design controls, and traceability built in. Every deliverable is scoped to support regulatory inspections, notified body audits, and FDA quality system expectations 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.

This system delivers structured documents and templates organized across core ISO 13485 process domains.

SECTION 1: Quality System Architecture Quality Manual · Quality Policy Template · Quality Objectives Framework · Organizational Roles & Responsibilities Matrix · QMS Scope Definition Template

SECTION 2: Document & Record Control Document Control Procedure · Record Control Procedure · Change Control Procedure · Master Document List Template · Controlled Form Template Set

SECTION 3: Design & Development Controls Design & Development Procedure · Design and Development Plan Template · Design Input Template · Design Output Template · Design Review Record Template · Design Verification Plan Template · Design Validation Plan Template · Design Transfer Procedure · Design Change Record Template · Design History File (DHF) Structure Blueprint

SECTION 4: Risk Management (ISO 14971 Aligned) Risk Management Procedure · Risk Management Plan Template · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk-Benefit Analysis Template · Residual Risk Evaluation Template

SECTION 5: Verification & Validation Framework Verification & Validation Master Plan · Test Protocol Template · Test Report Template · Requirements Traceability Matrix Template · Nonconformity Reporting Template

SECTION 6: CAPA & Nonconformance CAPA Procedure · CAPA Form Template · Nonconforming Product Procedure · Root Cause Analysis Template · Corrective Action Plan Template

SECTION 7: Supplier & Purchasing Controls Supplier Evaluation Procedure · Supplier Qualification Form · Approved Supplier List Template · Purchasing Controls Procedure · Supplier Monitoring Record Template

SECTION 8: Management & Audit Management Review Procedure · Management Review Minutes Template · Internal Audit Procedure · Internal Audit Checklist · Internal Audit Report Template

SECTION 9: Training & Competency Training Procedure · Training Record Template · Competency Evaluation Template · Training Matrix Template

SECTION 10: Post-Market & Feedback Complaint Handling Procedure · Complaint Record Template · Feedback & Post-Market Surveillance Procedure · Advisory Notice Template

SECTION 11: 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 medical device manufacturers, hardware-focused device teams, and quality professionals who need a complete, inspection-ready QMS without the complexity of a full software lifecycle integration. It's the right foundation whether you're establishing quality infrastructure for the first time, preparing for a notified body audit, or bringing your documentation up to standard ahead of an FDA inspection or strategic partnership.

What's Not Included

This system does not include IEC 62304 software lifecycle documentation, cybersecurity documentation, regulatory strategy consulting, or submission support. For organizations developing Software as a Medical Device, our AI-Accelerated Full QMS System (ISO 13485 + IEC 62304) provides the complete integrated solution. If your needs extend beyond documentation, please contact us for something that may be a better fit.

Designed for startups and scaling teams building regulated software systems. A comprehensive, audit-ready Quality Management System purpose-built for digital health and Software as a Medical Device (SaMD) environments.

This integrated system combines ISO 13485 quality management requirements with IEC 62304 software lifecycle controls, risk management alignment, and end-to-end traceability frameworks, delivering everything your team needs to operate, document, and demonstrate compliance without building from scratch.

Includes three 45-minute calls (onboarding, mid-point check-in, and final walkthrough) to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.

Delivery with 15 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, 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: 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, digital health startups, and medical device teams who need a complete, defensible QMS from the ground up — and need it to hold up under FDA scrutiny, notified body review, or investor due diligence. It's the right starting point whether you're preparing for a first 510(k) submission, pursuing CE marking under EU MDR, or establishing quality infrastructure ahead of a funding round.

What's Not Included

This system does not include cybersecurity documentation, regulatory strategy consulting, or submission support. For organizations developing networked or connected SaMD, our IEC 62304 + Cybersecurity QMS Add-On is available as a companion product. If your needs extend beyond documentation, please contact us for something that may be a better fit.