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 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.
Delivery within 10 business days.
