QMSR is now in effect. FDA enforcement began February 2, 2026. Is your quality system aligned? Assess your readiness

Assessments

Browse Assessments

21 pre-built maturity assessments for medical device quality systems. Every assessment references ISO 13485, FDA QSR/QMSR, EU MDR, and applicable IEC standards.

All Process Area CMMs AI CMM Suite Compliance & Gap Bundles

Process Area CMM

CAPA Management CMM

Assess and mature your corrective and preventive action system.

$2,499
8 dimensions

Process Area CMM

Complaint Handling CMM

Assess and mature your complaint handling process.

$2,499
8 dimensions

Process Area CMM

Design Controls CMM

Assess and mature your design control process.

$2,499
10 dimensions

Process Area CMM

Risk Management CMM

Assess and mature your risk management system.

$2,499
10 dimensions

Process Area CMM

Document Control CMM

Assess and mature your document control system.

$2,499
8 dimensions

Process Area CMM

Supplier Quality CMM

Assess and mature your supplier quality program.

$2,499
7 dimensions

Process Area CMM

Training & Competency CMM

Assess and mature your training and competency system.

$2,499
6 dimensions

Process Area CMM

Post-Market Surveillance CMM

Assess and mature your post-market surveillance program.

$2,499
8 dimensions

Process Area CMM

Clinical Affairs CMM

Assess and mature your clinical affairs capability.

$2,499
8 dimensions

Process Area CMM

Regulatory Readiness CMM

Assess and mature your regulatory readiness posture.

$2,499
10 dimensions

Process Area CMM

Production Controls CMM

Assess and mature your production control system.

$2,499
10 dimensions

Process Area CMM

Internal Audit Program CMM

Assess and mature your internal audit program.

$2,499
8 dimensions

AI CMM V1: Product Lifecycle

Assess AI maturity across the medical device product lifecycle.

$2,499
8 dimensions

AI CMM V2: Organizational Readiness

Assess your organization's readiness for AI adoption.

$2,499
8 dimensions

AI CMM V3: Regulatory Compliance

Assess AI regulatory compliance readiness.

$2,499
8 dimensions

AI CMM V4: Risk & Guardrails

Assess AI risk management and safety guardrails.

$2,499
8 dimensions

AI CMM V5: Workforce Integration

Assess workforce readiness for AI integration.

$2,499
13 dimensions

QMSR Transition Readiness

Assess readiness for the FDA QMSR transition.

$2,499
10 dimensions

FDA Inspection Prep

Prepare systematically for FDA inspections.

$2,499
8 dimensions

EU MDR Transition

Assess EU MDR transition readiness.

$2,499
8 dimensions

Quality Health Check

A rapid pulse-check on your overall quality system.

5-Pack Bundle

Choose any 5 assessments at a 28% discount.

Complete AI CMM Suite

All 5 AI CMM assessments — 45 dimensions of AI maturity.

$9,999
45 dimensions