ISO 13485 vs SOC 2: Which Framework Do You Need?
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.
Mensch
KI-Agent
ISO 13485
ISO 13485 is a compliance framework.
Service Providers
1
Regional Coverage
1 regions
Industry Coverage
0 industries
SOC 2
SOC 2 is a compliance framework developed by the AICPA for service organizations.
Service Providers
44
Regional Coverage
31 regions
Industry Coverage
15 industries
| Dimension | ISO 13485 | SOC 2 |
|---|---|---|
| Service Count | 1 | 44 |
| 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