ISO 13485
International standard for medical device quality management systems
U.S. SEC Cybersecurity Rules
U.S. SEC regulation for cybersecurity incident disclosure and governance
Quick Verdict
ISO 13485 mandates QMS for medical device safety worldwide, while U.S. SEC Cybersecurity Rules require public firms to disclose material cyber incidents within 4 days and annual governance. Medtech firms certify for market access; public companies comply for investor transparency.
ISO 13485
Medical devices — Quality management systems — Requirements for regulatory purposes
Key Features
- Risk-based QMS controls for device safety
- Regulatory requirements integration across lifecycle
- Mandatory process and design validation
- Traceability via medical device files
- Post-market surveillance and CAPA processes
U.S. SEC Cybersecurity Rules
Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure
Key Features
- Four-business-day material incident disclosure on Form 8-K
- Annual cybersecurity risk management disclosures in Form 10-K
- Board oversight and management role requirements
- Inline XBRL tagging for structured comparability
- Inclusion of third-party cybersecurity risks
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 an international certification standard specifying requirements for quality management systems (QMS) in medical device organizations. It applies to lifecycle stages from design to post-market activities, emphasizing a risk-based approach to ensure devices meet customer and regulatory requirements for safety and performance.
Key Components
- Clauses 4–8 cover QMS, management responsibility, resources, product realization, and measurement/improvement.
- Includes documented procedures, medical device files, validation, traceability, supplier controls, and CAPA.
- Built on process approach with regulatory integration; allows justified exclusions.
- Third-party certification via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks like recalls via validation and post-market surveillance.
- Builds stakeholder trust and supply chain assurance.
- Drives operational efficiency and compliance maturity.
Implementation Overview
- Phased: gap analysis, process design, documentation, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- 9–18 months typical; requires eQMS, training, management reviews.
U.S. SEC Cybersecurity Rules Details
What It Is
U.S. SEC Cybersecurity Rules (Release No. 33-11216) is a federal regulation mandating standardized disclosures for public companies. It requires timely reporting of material cybersecurity incidents and annual descriptions of risk management, strategy, and governance. The approach is materiality-based, aligned with securities law principles from cases like TSC Industries v. Northway.
Key Components
- **Incident disclosureForm 8-K Item 1.05 within four business days of materiality determination.
- **Periodic disclosureRegulation S-K Item 106 in Form 10-K, covering processes, board oversight, and management roles.
- Inline XBRL tagging for comparability.
- Built on existing disclosure frameworks; no fixed controls, emphasizes processes over technical details. No certification; compliance via SEC filings.
Why Organizations Use It
Enhances investor protection through timely, uniform information on cyber risks impacting operations and finances. Mandatory for Exchange Act registrants; reduces asymmetry, supports capital efficiency. Builds trust, mitigates enforcement risks like fines seen in Yahoo, Meta cases.
Implementation Overview
Cross-functional: integrate incident response with disclosure controls, develop materiality playbooks, update governance. Applies to all public companies (domestic, FPIs, SRCs, EGCs). Phased compliance from Dec 2023; involves gap analysis, training, XBRL readiness. No external audit required.
Key Differences
| Aspect | ISO 13485 | U.S. SEC Cybersecurity Rules |
|---|---|---|
| Scope | Medical device QMS lifecycle from design to post-market | Public company cyber incident and governance disclosures |
| Industry | Medical devices and suppliers globally | All SEC registrants, U.S. public companies |
| Nature | Voluntary certification standard for QMS | Mandatory SEC reporting regulation |
| Testing | Certification body audits, internal audits, validation | No formal testing; disclosure controls evaluation |
| Penalties | Loss of certification, no legal penalties | SEC enforcement, fines, civil penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and U.S. SEC Cybersecurity Rules
ISO 13485 FAQ
U.S. SEC Cybersecurity Rules FAQ
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