CMMC
DoD framework certifying cybersecurity for FCI and CUI
ISO 13485
International standard for medical device quality management systems
Quick Verdict
CMMC mandates cybersecurity certification for DoD contractors protecting FCI/CUI, while ISO 13485 provides voluntary QMS framework for medical device makers ensuring safety and regulatory compliance. Organizations adopt CMMC for contract eligibility; ISO 13485 for global market access and quality excellence.
CMMC
Cybersecurity Maturity Model Certification (CMMC) 2.0
Key Features
- Three tiered levels aligning to FCI and CUI protection
- Self-assessments or C3PAO/DIBCAC certifications every three years
- 110 NIST SP 800-171 controls at Level 2
- Limited POA&Ms requiring 180-day closures
- DFARS-mandated flow-down to subcontractors
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for device lifecycle processes
- Documented QMS with medical device files and traceability
- Design development verification and validation requirements
- Post-market surveillance complaints and CAPA systems
- Supplier evaluation and outsourcing process controls
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
CMMC Details
What It Is
Cybersecurity Maturity Model Certification (CMMC) 2.0 is a DoD certification program verifying cybersecurity protections for Federal Contract Information (FCI) and Controlled Unclassified Information (CUI) in the Defense Industrial Base (DIB). It uses a tiered model with three levels based on risk, drawing from FAR 52.204-21, NIST SP 800-171 Rev 2, and NIST SP 800-172.
Key Components
- 14 domains (e.g., Access Control, Incident Response) with 17 Level 1 practices, 110 Level 2, plus 24 Level 3 enhancements.
- Cumulative levels: Level 1 self-assess; Level 2 self or C3PAO; Level 3 DIBCAC post-Level 2.
- POA&Ms limited to 180 days; annual SPRS affirmations.
Why Organizations Use It
- Mandatory for DoD contracts to avoid ineligibility.
- Reduces breach risks, enhances supply chain trust.
- Provides competitive edge in bids; lowers insurance costs.
Implementation Overview
- Phased: scoping, gap analysis, remediation, assessment.
- Targets DIB contractors/subcontractors; 6-12 months typical.
- Requires SSP, evidence collection, triennial recertification.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard specifying requirements for a quality management system (QMS) tailored for medical devices and related services. It applies to organizations across the device lifecycle, from design to post-market activities, emphasizing regulatory compliance and risk-based controls for consistent safety and performance.
Key Components
- Organized into Clauses 4-8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Requires documented procedures, medical device files, validation, traceability, and CAPA.
- Built on process approach, aligned with ISO 9001 but with medical-specific enhancements like risk management (ISO 14971).
- Certification via accredited bodies with stage audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks of recalls, liabilities via robust controls.
- Builds stakeholder trust, supply chain assurance.
- Drives operational efficiency, cost savings.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Suits all sizes in medical devices globally.
- Involves eQMS adoption, cross-functional teams; 9-18 months typical.
Key Differences
| Aspect | CMMC | ISO 13485 |
|---|---|---|
| Scope | Cybersecurity for FCI/CUI protection | QMS for medical device lifecycle |
| Industry | DoD defense contractors globally | Medical device manufacturers worldwide |
| Nature | Mandatory certification for contracts | Voluntary QMS certification standard |
| Testing | Self/C3PAO/DIBCAC assessments triennially | Certification body audits, surveillance |
| Penalties | Contract ineligibility, debarment | Loss of certification, market access |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about CMMC and ISO 13485
CMMC FAQ
ISO 13485 FAQ
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