Framework overlap

Does ISO 13485 cover FedRAMP Moderate?

You hold ISO 13485 and have been told to do FedRAMP Moderate. Here is how much overlaps, control by control.

4% of FedRAMP Moderate you already have

ISO 13485 already covers about 4% of FedRAMP Moderate, leaving 229 of 238 controls as genuinely new work.

Already covered 1 Likely covered 8 New work 229

What is genuinely new work

Nothing in ISO 13485 reaches these. This is the list to scope.

AC-1
Policy and Procedures
AC-10
Concurrent Session Control
AC-11
Device Lock
AC-12
Session Termination
AC-14
Permitted Actions Without Identification or Authentication
AC-17
Remote Access
AC-17(1)
Monitoring and Control
AC-17(2)
Protection of Confidentiality and Integrity Using Encryption
AC-17(3)
Managed Access Control Points
AC-17(4)
Privileged Commands and Access
AC-18
Wireless Access
AC-18(1)
Authentication and Encryption
AC-19
Access Control for Mobile Devices
AC-19(5)
Full Device or Container-Based Encryption
AC-2(1)
Automated System Account Management
AC-2(12)
Account Monitoring for Atypical Usage
AC-2(13)
Disable Accounts for High-Risk Individuals
AC-2(2)
Automated Temporary and Emergency Account Management
AC-2(3)
Disable Accounts
AC-2(4)
Automated Audit Actions
AC-2(5)
Inactivity Logout
AC-2(7)
Privileged User Accounts
AC-2(9)
Restrictions on Use of Shared and Group Accounts
AC-20
Use of External Systems
AC-20(1)
Limits on Authorized Use
AC-20(2)
Portable Storage Devices Restricted Use
AC-21
Information Sharing
AC-22
Publicly Accessible Content
AC-4
Information Flow Enforcement
AC-4(21)
Physical or Logical Separation of Information Flows
AC-5
Separation of Duties
AC-6
Least Privilege
AC-6(1)
Authorize Access to Security Functions
AC-6(10)
Prohibit Non-Privileged Users from Executing Privileged Functions
AC-6(2)
Non-Privileged Access for Nonsecurity Functions
AC-6(5)
Privileged Accounts
AC-6(7)
Review of User Privileges
AC-6(9)
Log Use of Privileged Functions
AC-7
Unsuccessful Logon Attempts
AC-8
System Use Notification
AT-1
Policy and Procedures
AT-2
Literacy Training and Awareness
AT-2(2)
Insider Threat
AT-2(3)
Social Engineering and Mining
AT-3
Role-Based Training
AT-4
Training Records
AU-1
Policy and Procedures
AU-11
Audit Record Retention
AU-12
Audit Record Generation
AU-2
Event Logging
AU-3
Content of Audit Records
AU-3(1)
Additional Audit Information
AU-4
Audit Log Storage Capacity
AU-5
Response to Audit Logging Process Failures
AU-6
Audit Record Review, Analysis, and Reporting
AU-6(1)
Automated Process Integration
AU-6(3)
Correlate Audit Record Repositories
AU-7
Audit Record Reduction and Report Generation
AU-7(1)
Automatic Processing
AU-8
Time Stamps
AU-9
Protection of Audit Information
AU-9(2)
Store on Separate Physical Systems or Components
AU-9(4)
Access by Subset of Privileged Users
CA-1
Policy and Procedures
CA-2
Control Assessments
CA-2(1)
Independent Assessors
CA-3
Information Exchange
CA-5
Plan of Action and Milestones
CA-6
Authorization
CA-7
Continuous Monitoring
CA-7(1)
Independent Assessment
CM-1
Policy and Procedures
CM-10
Software Usage Restrictions
CM-11
User-Installed Software
CM-2
Baseline Configuration
CM-2(2)
Automation Support for Accuracy and Currency
CM-2(3)
Retention of Previous Configurations
CM-2(7)
Configure Systems and Components for High-Risk Areas
CM-3
Configuration Change Control
CM-3(2)
Testing, Validation, and Documentation of Changes
CM-3(4)
Security and Privacy Representatives
CM-4
Impact Analyses
CM-5
Access Restrictions for Change
CM-6
Configuration Settings
CM-6(1)
Automated Management, Application, and Verification
CM-7
Least Functionality
CM-7(1)
Periodic Review
CM-7(2)
Prevent Program Execution
CM-7(5)
Authorized Software Allow-by-Exception
CM-8
System Component Inventory
CM-8(1)
Updates During Installation and Removal
CM-8(3)
Automated Unauthorized Component Detection
CM-9
Configuration Management Plan
CP-1
Policy and Procedures
CP-10
System Recovery and Reconstitution
CP-2
Contingency Plan
CP-2(1)
Coordinate with Related Plans
CP-2(3)
Resume Mission and Business Functions
CP-3
Contingency Training
CP-4
Contingency Plan Testing
CP-4(1)
Coordinate with Related Plans
CP-6
Alternate Storage Site
CP-7
Alternate Processing Site
CP-8
Telecommunications Services
CP-9
System Backup
CP-9(1)
Testing for Reliability and Integrity
IA-1
Policy and Procedures
IA-11
Re-Authentication
IA-2
Identification and Authentication (Organizational Users)
IA-2(1)
MFA to Privileged Accounts
IA-2(12)
Acceptance of PIV Credentials
IA-2(2)
MFA to Non-Privileged Accounts
IA-2(8)
Access to Accounts Replay Resistant
IA-3
Device Identification and Authentication
IA-4
Identifier Management
IA-5
Authenticator Management
IA-5(1)
Password-Based Authentication
IA-5(2)
Public Key-Based Authentication
IA-5(6)
Protection of Authenticators
IA-6
Authentication Feedback
IA-7
Cryptographic Module Authentication
IA-8
Identification and Authentication (Non-Organizational Users)
IR-1
Event Detection and Triage
IR-3
Continuity of Operations
IR-4(1)
Automated Incident Handling Processes
IR-5
Incident Monitoring
IR-6
Incident Reporting
IR-6(1)
Automated Reporting
IR-7
Incident Response Assistance
IR-8
Incident Response Plan
MA-1
Policy and Procedures
MA-2
Controlled Maintenance
MA-4
Nonlocal Maintenance
MA-5
Maintenance Personnel
MP-1
Policy and Procedures
MP-2
Media Access
MP-3
Media Marking
MP-4
Media Storage
MP-5
Media Transport
MP-6
Media Sanitization
MP-7
Media Use
PE-1
Policy and Procedures
PE-12
Emergency Lighting
PE-13
Fire Protection
PE-14
Environmental Controls
PE-16
Delivery and Removal
PE-17
Alternate Work Site
PE-2
Physical Access Authorizations
PE-3
Physical Access Control
PE-6
Monitoring Physical Access
PE-8
Visitor Access Records
PL-1
Policy and Procedures
PL-2
System Security and Privacy Plans
PL-4
Rules of Behavior
PL-8
Security and Privacy Architectures
PS-1
Policy and Procedures
PS-2
Position Risk Designation
PS-3
Personnel Screening
PS-4
Personnel Termination
PS-5
Personnel Transfer
PS-6
Access Agreements
PS-7
External Personnel Security
PS-8
Personnel Sanctions
RA-2
Security Categorization
RA-5
Vulnerability Monitoring and Scanning
RA-5(2)
Update Vulnerabilities to be Scanned
RA-5(5)
Privileged Access
RA-7
Identifies and Analyzes Risk
SA-10
Developer Configuration Management
SA-11
Developer Testing and Evaluation
SA-2
Common Operating Picture
SA-3
System Development Life Cycle
SA-4
Acquisition Process
SA-4(10)
Use of Approved PIV Products
SA-5
System Documentation
SA-8
Security and Privacy Engineering Principles
SA-9
External System Services
SA-9(2)
Identification of Functions, Ports, Protocols, and Services
SC-1
Policy and Procedures
SC-10
Network Disconnect
SC-12
Cryptographic Key Establishment and Management
SC-13
Cryptographic Protection
SC-15
Collaborative Computing Devices and Applications
SC-17
Public Key Infrastructure Certificates
SC-18
Mobile Code
SC-2
Separation of System and User Functionality
SC-20
Secure Name/Address Resolution Service (Authoritative)
SC-21
Secure Name/Address Resolution Service (Recursive or Caching Resolver)
SC-22
Architecture and Provisioning for Name/Address Resolution Service
SC-23
Session Authenticity
SC-28
Protection of Information at Rest
SC-28(1)
Cryptographic Protection
SC-39
Process Isolation
SC-4
Information in Shared System Resources
SC-5
Denial-of-Service Protection
SC-7
Boundary Protection
SC-7(3)
Access Points
SC-7(4)
External Telecommunications Services
SC-7(5)
Deny by Default Allow by Exception
SC-7(7)
Split Tunneling for Remote Devices
SC-7(8)
Route Traffic to Authenticated Proxy Servers
SC-8
Transmission Confidentiality and Integrity
SC-8(1)
Cryptographic Protection
SI-1
Policy and Procedures
SI-10
Information Input Validation
SI-11
Error Handling
SI-12
Information Management and Retention
SI-16
Memory Protection
SI-2
Flaw Remediation
SI-2(2)
Automated Flaw Remediation Status
SI-3
Malicious Code Protection
SI-4
System Monitoring
SI-4(2)
Automated Tools and Mechanisms for Real-Time Analysis
SI-4(4)
Inbound and Outbound Communications Traffic
SI-4(5)
System-Generated Alerts
SI-5
Security Alerts, Advisories, and Directives
SI-7
Software, Firmware, and Information Integrity
SI-7(1)
Integrity Checks
SI-7(7)
Integration of Detection and Response
SI-8
Spam Protection
SR-1
Policy and Procedures (SR-1)
SR-10
Inspection of Systems or Components (SR-10)
SR-11
Component Authenticity (SR-11)
SR-12
Component Disposal (SR-12)
SR-2
Supply Chain Risk Management Plan (SR-2)
SR-3
Supply Chain Controls and Processes (SR-3)
SR-5
Acquisition Strategies, Tools, and Methods (SR-5)
SR-6
Supplier Assessments and Reviews (SR-6)
SR-8
Notification Agreements (SR-8)
Show the 9 you already have
RA-1
Policy and Procedures
AC-2
Account Management
AC-3
Access Enforcement
CA-8
Penetration Testing
CA-9
Internal System Connections
IR-2
Incident Response and Recovery
IR-4
Incident Handling
RA-3
Risk Assessment
SA-1
Logging and Monitoring

How this is calculated

Already covered means a mapping runs from a control in ISO 13485 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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