See where you are. See what's possible.
Pre-built maturity assessments for medical device companies. Diagnose gaps, benchmark your current state, and map the capabilities you need to build — without the six-figure consulting engagement.
You know improvement is needed.
But where — and toward what?
Quality gaps don't announce themselves — and future capabilities don't build themselves
Gaps show up as 483 observations, delayed submissions, audit findings that surprise leadership, and teams doing their best inside processes that weren't designed to scale.
But the bigger problem isn't just what's broken — it's what doesn't exist yet. Data infrastructure that enables predictive quality. Cross-functional governance that scales. Knowledge-sharing practices that position the company as an industry leader. These capabilities don't appear on their own. They have to be identified, planned, and resourced.
A Capability Maturity Model shows you both: where you are today and what best-in-class actually requires. Until now, getting one meant hiring a consultant.
Same rigor. Fraction of the cost.
Traditional Consulting
Hire an outside firm to assess your processes, interview your teams, and produce a report.
- ✗ 3–6 month engagement before deliverables
- ✗ Findings live in a PDF that goes stale
- ✗ Knowledge leaves when the consultant does
- ✗ Reassessment requires rebooking (and repaying)
- ✗ One-size-fits-all methodology
MedTechCMM Self-Directed
Your team runs a structured assessment that diagnoses current state and maps the capabilities you need to build next.
- ✓ Start scoring the same week you buy
- ✓ 8 integrated deliverables per assessment
- ✓ Your team builds internal assessment capability
- ✓ Reassess any time — the framework is yours
- ✓ Built specifically for regulated medtech
Three steps to clarity
Choose Your Assessment
Pick the process area, compliance target, or enterprise-wide view that matches your priority. Every assessment is purpose-built for medical device companies.
Get Your Deliverables
Receive your complete package up front — assessment framework, scoring rubrics, heatmap template, RACI matrix, gap analysis, regression diagnostic, prioritized roadmap, and facilitation guide. Everything you need before you begin.
Score With Your Team
Your cross-functional team runs the assessment using the deliverables provided. Walk through structured dimensions with clear maturity definitions, evidence requirements, and scoring criteria — on your timeline, no consultants required.
Built for medical device quality systems
Process Area CMMs — 12 Assessments
Deep-dive maturity assessments for specific QMS process areas. Diagnose current state, identify missing capabilities, and see what best-in-class looks like — across 5 maturity levels with full scoring criteria and regulatory mapping.
CAPA Management
Corrective and preventive action system maturity — from ad-hoc responses to predictive quality improvement.
Design Controls
Design and development process maturity covering planning, inputs, outputs, review, verification, validation, and transfer.
Risk Management
ISO 14971-aligned maturity assessment — from risk identification through post-production monitoring.
Document Control
Document and records management maturity — version control, retention, accessibility, and compliance.
Supplier Quality
Supplier management maturity from evaluation through ongoing monitoring, auditing, and performance trending.
Complaint Handling
End-to-end complaint lifecycle — intake, classification, investigation, MDR reporting, trending, and CAPA linkage.
Training & Competency
Training program maturity — needs analysis, delivery, effectiveness verification, and competency management.
Post-Market Surveillance
PMS system maturity — vigilance reporting, PMCF, trend analysis, periodic safety updates, field safety actions.
Clinical Affairs
Clinical evaluation and investigation maturity — CERs, PMCF, clinical data management, investigator oversight.
Regulatory Readiness
Regulatory affairs function maturity — submission management, intelligence, strategy, multi-market coordination.
Production Controls
Manufacturing and process control maturity — process validation, environmental controls, nonconforming product.
Internal Audit Program
Audit program maturity — planning, execution, reporting, follow-up, and continuous improvement of the audit function.
AI CMM Suite — 5 Assessments
The most comprehensive AI maturity assessment built for medical device companies. Five versions covering the full AI lifecycle — the future-forward capabilities that position your organization as an industry leader.
V1: AI in the Product Lifecycle
Assess how AI/ML is integrated into design, development, verification, and post-market surveillance of your medical devices.
V2: Organizational AI Readiness
Evaluate your organization's strategic alignment, governance, and cultural readiness for AI adoption at the leadership level.
V3: AI Regulatory Compliance
Measure your compliance posture against FDA PCCP, EU AI Act, MDR, and global AI-specific regulatory frameworks.
V4: AI Risk & Guardrails
Assess algorithmic risk management, bias controls, fail-safes, and human-in-the-loop decision frameworks.
V5: AI Workforce Integration
Evaluate how your teams understand, adopt, verify, and govern AI tools in daily workflows.
⭐ Complete AI CMM Suite
All 5 AI assessments at 20% off. The definitive AI maturity evaluation for medical device organizations.
Cross-Cutting Assessments — 4 Assessments
Enterprise-wide and compliance-specific assessments for leadership visibility, audit prep, and regulatory transitions.
Quality System Health Check
Enterprise-wide quality system diagnostic across 10 dimensions. Designed for annual or post-event assessment.
QMSR Transition Readiness
Gap assessment against the new Quality Management System Regulation across 10 dimensions.
FDA Inspection Prep
Pre-inspection readiness covering documentation, CAPA, complaints, supplier files, and key focus areas.
EU MDR Transition
Readiness assessment for EU MDR — technical documentation, PMS/PMCF, UDI, clinical evaluation.
Not just a score — a diagnostic and strategic toolkit
8 deliverables with every assessment
Maturity Assessment
Dimension-by-dimension scoring with five maturity levels, evidence criteria, and composite scoring. Your team walks through each area and rates your current state against clearly defined benchmarks.
The result is a defensible baseline you can present to leadership, auditors, or your board.
Color-Coded Heatmap
A visual snapshot across all dimensions. Red, yellow, green at a glance — leadership reads it in 30 seconds and immediately understands where you stand.
Pin it to the wall. Put it in your QMR deck. It's the single most powerful artifact for stakeholder alignment.
RACI Matrix
Who's responsible, accountable, consulted, and informed for every dimension. Eliminates the ambiguity that lets gaps persist.
Maps to your org structure so improvement work lands on specific desks, not vague teams.
Delta Map
Shows the change between assessments for every dimension — where you've grown, where you've held steady, and where you've slipped.
Run it after your second assessment to see exactly what moved and by how much. Positive, neutral, or negative — no guessing.
Regression Diagnostic
Six categories of what might pull scores backward over time — personnel changes, resource shifts, competing priorities, regulatory changes, and more.
Protect the gains you make. Know what to watch for before it erodes your maturity.
Assessment Instructions
Step-by-step facilitation guide for running the assessment without external help. Who to invite, how to score, how to resolve disagreements.
Your quality team leads the session. No consultants required.
Quick Reference Card
One-page summary of your maturity state, top gaps, and priority actions. Print it, pin it, use it in management reviews.
The artifact your VP of Quality carries into every leadership meeting.
Executive Readout Template
Pre-built briefing structure your VP of Quality carries into the leadership meeting. Full heatmap, low-score flags, dimensions with no activity at all, and feasibility notes — what it actually takes to close each gap, including resource requirements for standing up capabilities that don't yet exist.
Low scores surface improvement conversations. No-activity dimensions surface investment conversations — headcount, budget, infrastructure, training. Upper-level gaps surface feasibility — where advancing requires data infrastructure or an industry knowledge-sharing posture. The template structures all three.
Workforce Dev: no activity recorded
Data Mgmt: 1.8 — intervention candidate
L4+: data infrastructure investment
L5: industry knowledge-sharing commitment
Your assessment data, interpreted by an expert
Not a generic chatbot. An AI trained on MedTechCMM's scoring methodology, maturity model structure, and what each level actually requires — including the infrastructure, governance, and organizational capabilities behind every score.
See Plans →“Can't I just upload my assessment to ChatGPT?”
Generic AI (ChatGPT, Claude, etc.)
- No context on maturity model structure or scoring methodology
- Can't interpret what each level actually requires to achieve
- Won't detect cross-assessment patterns or systemic gaps
- Can't coach you on executive presentation or resource framing
- No memory between sessions — starts from zero every time
- Generic answers that could apply to any industry
MedTechCMM AI Insight Partner
- Trained on MedTechCMM methodology — knows what every score means
- Understands what each maturity level requires: people, process, infrastructure
- Detects patterns across assessments your team would miss
- Coaches executive readout — flags, feasibility, resource requirements
- Retains context across sessions — gets smarter about your organization
- Medical device specific — regulatory, quality, and compliance context built in
Assessment packages for every scope
Individual
Single process area or cross-cutting assessment with the full 8-deliverable package.
- ✓ Full maturity or gap assessment
- ✓ All 8 deliverables included
- ✓ Self-directed facilitation guide
- ✓ Reassess unlimited times
5-Pack Bundle
Any 5 assessments from the full portfolio. Best for multi-process-area assessment.
- ✓ Any 5 assessments, your choice
- ✓ Full deliverable package each
- ✓ Cross-assessment comparison view
- ✓ Priority support
AI Insight Partner
Upload completed assessments. Get expert interpretation, pattern detection, and executive readout coaching.
- ✓ Upload & analyze any completed assessment
- ✓ Cross-assessment pattern detection
- ✓ Executive readout coaching
- ✓ Org context retained across sessions
- ✓ Feasibility & resource framing
AI Insight Partner works with any purchased assessment. See how it compares to generic AI.
Beyond the assessment
Your assessment shows you both the gaps and the future-state capabilities your organization needs. Building those capabilities at scale — cascading best practices to the right person, at the right level, at the moment they need them — requires operational infrastructure.
That's Coherence Frameworks. The system that turns assessment insights into installed organizational capability.
Explore Coherence Frameworks →Assess
Diagnose current state. Identify gaps and the capabilities you need to build.
Present
Executive readout surfaces resource needs, feasibility, and the case for investment.
Implement
Coherence Frameworks installs the capabilities — governed guidance to the right people, right time.
Reassess
Measure what moved. Track regression. Demonstrate capability growth.
Stop guessing. Start building forward.
Your quality system is only as strong as your ability to see it clearly — and your strategy is only as good as your ability to see what's next.
Trusted by quality leaders in regulated medical device companies