QMSR / ISO 13485 Readiness Platform
Professional medical device QMSR and ISO 13485 readiness assessment powered by specialized Cruxi AI quality-system agents. Identify missing procedures, weak SOPs, design-control gaps, risk-management gaps, CAPA weaknesses, supplier-control issues, and implementation priorities before audit, inspection, manufacturing, launch, investor diligence, or expert remediation.
2–4 hours. Guided workflow. Expert review available.
The Cruxi Way: QMS Readiness Without Consultant Discovery Chaos
Start with Cruxi's AI quality-system agents. Finish with expert review. Get a structured QMS gap map, missing-document checklist, implementation roadmap, and expert-reviewed path to readiness.
FDA's revised Part 820 is now titled the Quality Management System Regulation (QMSR), effective February 2, 2026, and incorporates ISO 13485:2016 as the foundation for medical device quality management system requirements.
Cruxi AI Assesses Your QMSR / ISO 13485 Readiness
2–4 hours
- check_circleEnter your company, device, manufacturing, and market information through a guided workflow
- check_circleCruxi identifies your QMS maturity level: no QMS, template QMS, partial QMS, implemented QMS, or audited/certified QMS
- check_circleAI quality-system agents map your intake and documents against core QMSR / ISO 13485 quality areas
- check_circleCruxi identifies missing SOPs, weak procedures, missing records, and implementation gaps
- check_circleDesign-control and DHF readiness agents review user needs, design inputs, outputs, V&V, traceability, and DHF completeness
- check_circleRisk-management agents assess your risk file, risk controls, residual-risk logic, and links to verification and post-market monitoring
- check_circleGenerate a QMS readiness score, gap matrix, missing-document checklist, and 30/60/90-day remediation roadmap
Powered by Cruxi AI quality-system agents
Expert Review & QMS Remediation Support
Optional but Recommended
- check_circleVetted QMSR / ISO 13485 consultant reviews your Cruxi-generated readiness report
- check_circleExpert validates QMS gaps, document weaknesses, design-control issues, and remediation priorities
- check_circleConsultant helps finalize your implementation roadmap for audit, inspection, certification, launch, or due diligence readiness
- check_circleProvider can offer QMS buildout, SOP finalization, DHF remediation, CAPA/complaint process setup, and implementation support
Saves consultant discovery time. Expert starts from a structured QMS assessment instead of a blank page.
Your company information, quality documents, device details, and uploaded materials are kept confidential and stay within Cruxi's platform and AI workflow unless you explicitly authorize sharing with a provider for a quote or expert review.
Cruxi can connect you to a vetted consultant once your QMS readiness package is prepared. Any human consultant review or follow-on implementation work is an independent professional service provided directly by the consultant, not by Cruxi. Cruxi facilitates workflow, pricing, communication, and provider matching.
Why This Approach?
Two Experts arrow_downward Time
You get both AI and human expertise. Cruxi performs the heavy first pass: intake, document inventory, gap mapping, SOP checklist, design-control review, risk-management review, and implementation planning. Then a human expert reviews and finalizes the roadmap.
Lower Discovery Cost arrow_downward Cost
Traditional QMS consulting often starts with expensive discovery. Cruxi organizes your QMS information first, so the consultant can focus on judgment, remediation, and implementation instead of manually sorting through scattered files.
Better Readiness Visibility arrow_upward Quality
Cruxi helps you see what is missing before you face an audit, FDA inspection, ISO 13485 certification effort, investor diligence, manufacturing scale-up, or launch milestone.
Need a human expert? Cruxi can connect you with vetted QMSR / ISO 13485 consultants.
Find vetted QMSR / ISO 13485 consultantsWhat Cruxi Assesses
Cruxi reviews your QMS readiness across the areas most medical device companies need to control.
Company & Quality Scope
Primary quality owner, regulatory contact, management representative, manufacturing role, target markets, and provider coordination details.
Device type, device stage, manufacturing model, outsourced partners, markets, device complexity, and QMS scope.
Current QMS maturity, ISO 13485 certification status, eQMS usage, audit history, inspection history, open CAPAs, complaints, and existing procedures.
Document & Process Readiness
Identify which SOPs, records, forms, logs, DHF artifacts, risk files, supplier records, audit reports, and management review materials exist.
Cruxi requests the most important documents first instead of asking for your entire QMS folder.
AI maps your documents and intake responses against core QMS areas including document control, management review, design controls, risk management, CAPA, complaints, supplier controls, training, production controls, and records.
Gap Analysis & Remediation
Find missing procedures, generic templates, weak SOPs, missing records, undefined responsibilities, and lack of implementation evidence.
Review user needs, design inputs, outputs, verification, validation, design reviews, traceability, DHF index, and design-transfer gaps.
Assess risk-management plan, hazard analysis, risk controls, verification links, residual risk, benefit-risk rationale, and post-market risk monitoring.
Review CAPA, complaints, supplier qualification, training, internal audit, management review, nonconformance, change control, labeling control, and production-release processes.
Complete QMSR / ISO 13485 Readiness Workflow
From company intake to expert-reviewed remediation roadmap — every step structured, scored, and packaged.
Step-by-Step Readiness Process
Our guided workflow takes you through each phase of QMS readiness, ensuring nothing important is missed. From company scope to final readiness report, every step is structured for expert review and implementation planning.
- personCompany & Quality Contacts
- businessBusiness & Device Scope
- assignmentQMS Status Intake
- folderDocument Inventory
- cloud_uploadSmart Document Upload
- ruleQMSR / ISO 13485 Mapping
- searchGap Assessment
- device_hubDesign Controls & DHF Readiness
- shieldRisk Management Readiness
- settingsOperational Quality Readiness
- analyticsReadiness Score & Remediation Plan
- descriptionQMS Document Builder
- psychologyCompliance Advisor
- check_circleFinal Readiness Report
- downloadExport & Package
- groupsConnect with Expert
QMSR / ISO 13485 Microservices
Use the complete workflow or individual readiness tools.
QMS Readiness Assessment
QMS Readiness Assessment
AI-powered QMS maturity and gap assessment. Identify missing procedures, weak SOPs, missing records, and implementation gaps across your medical device quality system.
- auto_awesomeQMS maturity classification
- checklistMissing SOP checklist
- analyticsReadiness score and gap matrix
Design Controls / DHF Gap Review
Design Controls / DHF Gap Review
Assess whether your design history file is complete, traceable, and ready for expert review. Map gaps across user needs, design inputs, outputs, V&V, design reviews, risk controls, and traceability.
- device_hubDHF gap mapping
- account_treeTraceability assessment
- ruleDesign-control readiness score
Risk Management File Review
Risk Management File Review
Assess whether your risk-management process is documented, linked to design controls, and supported by evidence.
- warningHazard and risk-control gap map
- verifiedRisk-to-verification linkage review
- sourceResidual-risk and post-market monitoring checklist
CAPA, Complaint & Post-Market Readiness
CAPA, Complaint & Post-Market Readiness
Review whether your quality system has the operational processes needed to handle complaints, nonconformances, CAPA, post-market signals, and quality records.
- report_problemComplaint process review
- buildCAPA workflow gap map
- fact_checkRecord and implementation evidence checklist
QMS Document Builder
QMS Document Builder
Generate first-draft SOPs, templates, forms, logs, checklists, and implementation materials based on your actual company and device profile.
- descriptionDraft SOP generation
- checklist_rtlForms and logs
- editExpert-review-ready templates
Why Choose Cruxi for QMSR / ISO 13485 Readiness
Cruxi is not traditional QMS software. It is a readiness engine that analyzes your device, company stage, QMS documents, SOP inventory, design controls, risk management, and implementation evidence — then turns scattered information into a structured readiness report and remediation plan.
QMSR / ISO 13485 Gap Mapping
Identify missing procedures, records, and implementation gaps
Evidence-Based Findings
Link findings to intake responses and uploaded documents
Expert-Ready Brief
Give consultants a structured package instead of messy folders
Design Controls & DHF Review
Find gaps in design inputs, outputs, V&V, traceability, and DHF structure
Risk Management Readiness
Map missing risk controls, residual-risk logic, and verification links
Expert Review Available
Add a vetted QMS consultant for validation and implementation support
How Cruxi Works: AI Quality-System Agents
Behind every QMSR / ISO 13485 readiness assessment, specialized Cruxi agents handle intake, document classification, gap mapping, scoring, and draft remediation planning — while your quality owner and expert consultants remain in full control.
business QMS Scope Agent
Analyzes company role, device stage, manufacturing model, markets, product type, and quality responsibilities to define the QMS scope.
folder_managed Document Inventory Agent
Classifies uploaded documents, identifies missing SOPs, detects generic template language, and builds a document coverage map.
search Gap Assessment Agent
Maps procedures, records, forms, logs, and evidence against core QMSR / ISO 13485 quality-system areas.
device_hub Design Controls Agent
Assesses whether user needs, design inputs, design outputs, verification, validation, design reviews, risk links, and traceability are present and organized.
warning Risk Management Agent
Reviews the presence and completeness of risk-management files, hazard analysis, risk controls, verification links, residual risk, and production/post-production monitoring.
psychology Compliance Advisor Agent
Summarizes readiness risks in plain English and recommends remediation priorities before expert review.
shield_person Built for Readiness, Not AI Overconfidence
Cruxi does not certify your QMS. Cruxi does not replace ISO auditors, FDA inspectors, notified bodies, or qualified consultants.
Cruxi prepares a structured readiness assessment, gap map, draft documents, and expert-ready work package so your team and consultants can move faster and with fewer blind spots.
- Human-in-the-loop by design: Every finding is assistive and should be reviewed by your quality/regulatory owner or consultant.
- Traceable to your information: Findings are based on your intake responses, document inventory, and uploaded files.
- No black box compliance claims: Cruxi shows why a gap was flagged and what document or process appears missing.
- Your data stays yours: Your QMS documents and company information are used to serve your project, not to train public AI models.
What You Get
A complete, structured QMS readiness package ready for your team and expert review.
Final Readiness Report
Executive summary, QMS scope, maturity level, readiness score, and risk areas.
Gap Matrix
Area-by-area coverage showing covered, partial, missing, and not applicable items.
Missing Document Checklist
SOPs, records, forms, logs, and implementation evidence needed for your stage.
Design Controls / DHF Gap Map
User needs, design inputs, outputs, V&V, design reviews, traceability, and DHF gaps.
Risk Management Gap Map
Risk file, hazard analysis, risk controls, residual risk, and post-market monitoring gaps.
30/60/90-Day Remediation Roadmap
Prioritized implementation plan for QMS buildout or remediation.
Draft SOP Bundle
First-draft quality documents and templates for expert review.
Expert-Ready Brief
Structured package your consultant can review quickly without starting from scratch.
Who Needs This?
Medical device companies at every stage of QMS maturity benefit from structured readiness assessment.
Medtech Startups Preparing for FDA Submission
You have a device and maybe a draft submission plan, but your QMS, DHF, risk file, and SOPs are incomplete.
Companies Preparing for Manufacturing or Launch
You need document control, supplier controls, production records, training, CAPA, complaints, and release processes before scaling.
Foreign Manufacturers Entering the U.S.
You may already have ISO-style documents but need to understand QMSR alignment and FDA-specific readiness.
SaMD and Software Device Companies
You need design controls, software lifecycle documentation, change control, cybersecurity processes, validation evidence, complaints, CAPA, and post-market monitoring.
Companies Preparing for Investor Diligence or Acquisition
You need to show your quality system is not just templates — it is structured, documented, and ready for expert review.
Companies With Existing QMS Gaps
You have SOPs, but you are unsure whether they are complete, implemented, or aligned with QMSR / ISO 13485 expectations.
Important Note
This is a preliminary QMSR / ISO 13485 readiness assessment based on your intake responses and documents provided. It is not an ISO certification audit, FDA inspection determination, legal opinion, regulatory opinion, or guarantee of compliance. Expert review is recommended before relying on the results for FDA inspection, ISO certification, investor diligence, manufacturing launch, market access, or formal quality-system implementation.
Frequently Asked Questions
What is QMSR?
QMSR is FDA's updated Quality Management System Regulation for medical devices. It became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference into FDA's medical device quality system framework.
Is ISO 13485 certification required by FDA?
No. FDA explains that QMSR incorporates ISO 13485:2016, but FDA does not require an ISO 13485 certificate as a substitute for FDA requirements or inspection. The goal is QMS readiness and compliance alignment, not simply obtaining a certificate.
Does Cruxi certify my QMS?
No. Cruxi does not certify your QMS and does not act as an ISO certification body, FDA inspector, or notified body. Cruxi helps identify likely gaps, organize evidence, draft documents, and prepare an expert-ready remediation package.
Can Cruxi assess my QMS without all documents?
Yes. Cruxi can generate an intake-based preliminary readiness scan using structured questions and any available documents. For stronger results, upload your Quality Manual, SOP index, Document Control SOP, Design Control SOP, Risk Management SOP or risk file, CAPA SOP, Complaint Handling SOP, Supplier Control SOP, Training SOP or training matrix, and any recent audit report or prior gap assessment.
What documents should I upload first?
Start with:
- Quality Manual
- SOP index or document master list
- Document Control SOP
- Design Control SOP
- Risk Management SOP or risk file
- CAPA SOP
- Complaint Handling SOP
- Supplier Control SOP
- Training SOP or training matrix
- Recent audit report or prior gap assessment, if available
Is this for companies starting from scratch?
Yes. If you do not have a QMS yet, Cruxi can generate a starting roadmap, missing document list, draft SOP package, and expert-ready implementation brief.
Is this for companies that already have ISO 13485?
Yes. Existing ISO 13485-certified or audited companies can use Cruxi to check QMSR alignment, identify FDA-specific gaps, organize evidence, and prepare for expert review.
Does Cruxi replace a QMS consultant?
No. Cruxi reduces the discovery and organization burden. A qualified consultant should review, validate, and finalize the QMS roadmap, especially before audit, inspection, certification, manufacturing, or launch.
What does the expert review include?
Expert review can include validation of the Cruxi readiness report, review of major gaps, SOP comments, remediation priorities, QMS implementation planning, DHF/design-control remediation, CAPA/complaint process review, and follow-on implementation support.
Can I use Cruxi before hiring a consultant?
Yes. That is the point. Cruxi helps you understand what you have, what is missing, what is weak, and what expert help you actually need before paying for open-ended consultant discovery.
lock Is my confidential QMS information used to train public AI models?
No. Your QMS documents, company information, and project materials are kept within Cruxi's environment and are not used to train public models. They are used solely to serve your projects and power your workspace.
Ready to Assess Your QMSR / ISO 13485 Readiness?
Join medical device companies using Cruxi AI quality-system agents to identify QMS gaps, organize documents, prepare remediation roadmaps, and connect with expert review.
Start Your QMSR / ISO 13485 Readiness AssessmentNeed a human expert? Cruxi can connect you with vetted QMSR / ISO 13485 consultants once your readiness package is prepared.