ISO 13485 vs SOC 2 - Compare Compliance Frameworks | ISMS Directory

ISO 13485 vs SOC 2: Which Framework Do You Need?

Humano

Agente IA

Wondering whether to pursue ISO 13485 or SOC 2 certification? This comparison covers the key differences between these frameworks, the number of service providers available for each, and guidance on which might be the right choice for your organization.

Humano

Agente IA

ISO 13485

ISO 13485 is a compliance framework.

Service Providers

Regional Coverage

1 regions

Industry Coverage

0 industries

Browse all ISO 13485 services →

SOC 2

SOC 2 is a compliance framework developed by the AICPA for service organizations.

Service Providers

Regional Coverage

31 regions

Industry Coverage

15 industries

Browse all SOC 2 services →

Dimension	ISO 13485	SOC 2
Service Count	1	41
Regions	Global	Africa Asia Australia Austria Belgium Brazil Canada Denmark +23 more
Industries		Construction Cryptocurrency Finance Government Healthcare Hospitality +9 more

Which Do You Need?

Choose ISO 13485 if:

- Your clients or partners require ISO 13485 certification
- You operate in regions where ISO 13485 is the standard
- You need a ISO 13485-specific compliance approach

Choose SOC 2 if:

- Your clients or partners require SOC 2 certification
- You operate in regions where SOC 2 is the standard
- You need a trust-based compliance report approach

ISO 13485 vs SOC 2: Which Framework Do You Need?

ISO 13485

SOC 2

Which Do You Need?

Choose ISO 13485 if:

Choose SOC 2 if:

Preguntas frecuentes

What is the difference between ISO 13485 and SOC 2?

Can I get both ISO 13485 and SOC 2 certified?

Which framework should I pursue first, ISO 13485 or SOC 2?