SOC 2
AICPA framework for service organizations' security controls
ISO 13485
International standard for medical device quality management systems
Quick Verdict
SOC 2 provides voluntary trust services attestation for SaaS data security, while ISO 13485 mandates rigorous QMS for medical devices. Tech firms adopt SOC 2 for enterprise sales; medtech uses ISO 13485 for regulatory market access and patient safety.
SOC 2
System and Organization Controls 2
Key Features
- Trust Services Criteria with mandatory Security foundation
- Type 2 reports prove operating effectiveness over time
- Flexible scoping for service organizations' systems
- AICPA CPA independent attestation for credibility
- Overlaps 80% with ISO 27001 controls
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS for medical device lifecycle
- Documented processes and traceability requirements
- Design controls and process validation
- 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.
SOC 2 Details
What It Is
SOC 2 (System and Organization Controls 2) is a voluntary attestation framework developed by the AICPA to evaluate service organizations' controls over customer data. It focuses on Trust Services Criteria (TSC)—Security (mandatory), Availability, Processing Integrity, Confidentiality, and Privacy—using a risk-based, control-oriented approach for cloud, SaaS, and tech services.
Key Components
- Five TSC with Common Criteria (CC1-CC9) foundation under Security.
- Approximately 50-100 controls mapped to TSC, requiring redundancy (2-3 per category).
- Built on AICPA principles; Type 1 (design) and Type 2 (design + effectiveness) reports.
- CPA-led audits with evidence like logs, policies, and pen tests.
Why Organizations Use It
- Accelerates enterprise sales, unlocks deals via due diligence streamlining.
- Builds stakeholder trust, reduces breach risks ($9K/min downtime).
- Market-driven (not legal mandate) yet required by Fortune 500 buyers.
- Competitive moat with ROI in 3-6 months through higher ACVs.
Implementation Overview
- Phased: gap analysis (2-4 weeks), deployment (4-8 weeks), monitoring (3-12 months), audit.
- Targets SaaS/fintech (10-500+ employees); automation tools like Vanta.
- Annual Type 2 recertification by AICPA CPAs; scalable globally.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a certifiable framework for risk-based QMS tailored to medical device lifecycle stages, from design to post-market surveillance.
Key Components
- Organized into **Clauses 4–8QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
- Emphasizes documented processes, validation, traceability, risk management (ISO 14971), supplier controls, CAPA.
- Built on process approach; certification via accredited bodies with stage 1/2 audits, surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment 2026), reduces regulatory friction.
- Mitigates patient safety risks, lowers recalls/costs via validation, post-market vigilance.
- Builds stakeholder trust, competitive edge for suppliers/manufacturers.
Implementation Overview
- Phased: gap analysis, process design, documentation, validation, audits.
- Applies to manufacturers, suppliers globally; 9–18 months typical, eQMS recommended.
Key Differences
| Aspect | SOC 2 | ISO 13485 |
|---|---|---|
| Scope | Security, availability, confidentiality, processing integrity, privacy via TSC | QMS for medical device lifecycle: design, production, post-market |
| Industry | SaaS, cloud, tech service organizations globally | Medical device manufacturers, suppliers worldwide |
| Nature | Voluntary AICPA attestation framework | Regulatory-purpose QMS certification standard |
| Testing | Type 1/2 CPA audits over 3-12 months | Certification body audits: stage 1/2, surveillance |
| Penalties | Market exclusion, lost deals, no legal fines | Regulatory enforcement, market bans, fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about SOC 2 and ISO 13485
SOC 2 FAQ
ISO 13485 FAQ
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