ISO 13485
International standard for medical device quality management systems
FedRAMP
U.S. government framework standardizing cloud security authorization
Quick Verdict
ISO 13485 ensures medical device quality worldwide via auditable QMS, while FedRAMP standardizes US federal cloud security through rigorous assessments. Manufacturers adopt ISO 13485 for global compliance; CSPs pursue FedRAMP for government contracts.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for device safety and compliance
- Full lifecycle coverage from design to post-market
- Mandatory medical device files for traceability
- Process and software validation requirements
- Post-market surveillance and regulatory reporting
FedRAMP
Federal Risk and Authorization Management Program
Key Features
- Assess once, use many times principle
- NIST SP 800-53 Rev 5 baselines with overlays
- Independent 3PAO security assessments
- Continuous monitoring with monthly deliverables
- Three impact levels plus LI-SaaS baseline
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international certification standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework for organizations to demonstrate consistent provision of safe medical devices meeting customer and regulatory needs across the device lifecycle.
Key Components
- Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
- Emphasizes documented procedures, traceability, validation, and risk management (linked to ISO 14971).
- Requires medical device files, supplier controls, CAPA, and post-market surveillance.
- 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, continual improvement.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- Timelines 9–18 months typical; involves eQMS, cross-functional teams.
FedRAMP Details
What It Is
FedRAMP (Federal Risk and Authorization Management Program) is a U.S. government-wide framework standardizing security assessment, authorization, and continuous monitoring for cloud services used by federal agencies. Its risk-based approach leverages NIST SP 800-53 Rev 5 controls tailored to cloud environments, enabling "assess once, use many times."
Key Components
- **Three impact levelsLow (~156 controls), Moderate (~323), High (~410), plus LI-SaaS for low-risk SaaS.
- Core artifacts: SSP, SAR, POA&M, continuous monitoring plans.
- Built on FIPS 199 categorization and independent 3PAO assessments.
- Compliance via Agency or Program Authorizations.
Why Organizations Use It
- Unlocks federal contracts worth $20M+.
- Mandatory for CMMC contractors; presumption of adequacy for agencies.
- Enhances risk management, reduces duplication.
- Builds trust, differentiates in commercial markets.
Implementation Overview
- Multi-phase: preparation, 3PAO assessment, authorization, monitoring.
- Suited for CSPs targeting U.S. federal market.
- Requires specialized teams, documentation; audited by accredited 3PAOs.
Key Differences
| Aspect | ISO 13485 | FedRAMP |
|---|---|---|
| Scope | Medical device QMS lifecycle | Cloud security assessment/monitoring |
| Industry | Medical devices globally | US federal cloud services |
| Nature | Voluntary certification standard | Mandatory US government program |
| Testing | Certification body audits | 3PAO independent assessments |
| Penalties | Loss of certification | Market exclusion, contract loss |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and FedRAMP
ISO 13485 FAQ
FedRAMP FAQ
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