FISMA
U.S. law for risk-based federal cybersecurity management
ISO 13485
International standard for medical device quality management systems
Quick Verdict
FISMA mandates risk-based cybersecurity for US federal systems via NIST RMF, while ISO 13485 certifies QMS for medical devices ensuring safety and compliance. Agencies/contractors adopt FISMA for legal obligations; medtech firms pursue ISO 13485 for global market access and quality assurance.
FISMA
Federal Information Security Modernization Act (FISMA)
Key Features
- Mandates NIST RMF 7-step risk management process
- Requires continuous monitoring and diagnostics (CDM)
- Categorizes systems by FIPS 199 impact levels
- Imposes annual independent IG assessments
- Extends to federal agencies and contractors
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls across device lifecycle
- Design development and validation requirements
- Medical device files and traceability
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing controls
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
FISMA Details
What It Is
Federal Information Security Modernization Act (FISMA) is a U.S. federal law providing a risk-based framework for securing federal information and systems. Enacted in 2002 and updated in 2014, it mandates agency-wide security programs using NIST Risk Management Framework (RMF) to ensure confidentiality, integrity, and availability.
Key Components
- **7-step NIST RMFPrepare, Categorize (FIPS 199), Select/Implement/Assess (NIST SP 800-53 controls), Authorize, Monitor.
- Continuous diagnostics and mitigation (CDM).
- Annual reporting and Inspectors General (IGs) independent evaluations.
- Oversight by OMB, CISA, DHS.
Why Organizations Use It
Mandatory for federal agencies and contractors handling federal data; reduces breach risks, enables contracts, builds resilience and trust. Noncompliance risks debarment, funding loss; compliance provides market access, efficiency.
Implementation Overview
Phased RMF lifecycle with SSPs, POA&Ms, ATOs; applies to agencies, contractors, cloud via FedRAMP. Involves inventories, assessments, automation; scalable for large/small organizations.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international quality management system (QMS) standard for medical devices and related services, titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework ensuring consistent conformity to customer and regulatory requirements across the device lifecycle, from design to post-market surveillance.
Key Components
- Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, validation, traceability, risk management (per ISO 14971), and medical device files.
- Certification model via accredited bodies with Stage 1/2 audits, surveillance, and recertification every 3 years.
Why Organizations Use It
- Facilitates market access (EU MDR, FDA QMSR by 2026).
- Mitigates risks of recalls, non-conformities, and liabilities.
- Enhances operational efficiency, supplier control, and stakeholder trust.
Implementation Overview
- Phased: gap analysis, process design, documentation/validation, internal audits, certification.
- Suits manufacturers/suppliers globally; 9–18 months typical, cross-functional effort required.
Key Differences
| Aspect | FISMA | ISO 13485 |
|---|---|---|
| Scope | Federal info systems security via NIST RMF | Medical device QMS lifecycle and regulatory compliance |
| Industry | US federal agencies and contractors | Global medical device manufacturers/suppliers |
| Nature | US federal law, mandatory for agencies | Voluntary international certification standard |
| Testing | Continuous monitoring, IG annual assessments | Internal audits, certification body surveillance |
| Penalties | Contract loss, debarment, IG reports | Certification loss, market access denial |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about FISMA and ISO 13485
FISMA FAQ
ISO 13485 FAQ
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