WCAG
Global standard for web content accessibility to disabilities
ISO 13485
International standard for medical device quality management systems
Quick Verdict
WCAG provides testable web accessibility guidelines for all organizations worldwide, while ISO 13485 mandates rigorous QMS for medical device makers. Companies adopt WCAG to mitigate lawsuits and enhance UX; ISO 13485 ensures regulatory compliance and market access.
WCAG
Web Content Accessibility Guidelines (WCAG) 2.1
Key Features
- Four POUR principles (Perceivable, Operable, Understandable, Robust)
- Testable success criteria at A/AA/AAA conformance levels
- Backward-compatible additive versioning across 2.0/2.1/2.2
- Technology-agnostic requirements for web and future tech
- Strict conformance for full pages and processes
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS processes and controls
- Design development and validation requirements
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing controls
- Traceability and medical device file maintenance
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
WCAG Details
What It Is
Web Content Accessibility Guidelines (WCAG) 2.1 is the W3C's technology-agnostic framework for making web content accessible to people with disabilities. Its primary purpose is to provide testable success criteria under four POUR principles: Perceivable, Operable, Understandable, Robust, covering visual, auditory, motor, cognitive needs.
Key Components
- 13 guidelines organized under POUR, with ~80 success criteria at Levels A, AA, AAA.
- Normative requirements separate from informative techniques and failures.
- Conformance model requires full pages, complete processes, accessibility-supported tech, non-interference.
Why Organizations Use It
- Meets legal benchmarks (ADA, Section 508, EN 301 549, EAA).
- Reduces litigation risk, improves UX/conversion, expands market reach.
- Enhances SEO, reduces support costs, builds stakeholder trust.
Implementation Overview
Phased program: policy/governance, assessment, remediation via design systems/CI tools, training, audits. Applies to all org sizes/industries globally; no formal certification but VPAT/ACR for procurement.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard specifying requirements for a quality management system (QMS) tailored to medical devices and related services. It applies across the device lifecycle—from design to post-market surveillance—for regulatory purposes, using a risk-based process approach.
Key Components
- Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, validation, traceability, risk management (linked to ISO 14971), supplier controls, and post-market obligations.
- Requires certification via accredited bodies with stage audits and surveillance.
Why Organizations Use It
- Enables market access (e.g., EU MDR, FDA QMSR alignment by 2026), reduces risks, ensures compliance.
- Drives operational excellence, cost savings, stakeholder trust, and scalability.
Implementation Overview
- Phased: gap analysis, process design, documentation, validation, audits.
- Suits manufacturers, suppliers, all sizes; global applicability with 9–18 months typical timeline.
Key Differences
| Aspect | WCAG | ISO 13485 |
|---|---|---|
| Scope | Web content accessibility for disabilities | Medical device QMS lifecycle and compliance |
| Industry | All web-publishing organizations globally | Medical device manufacturers and suppliers |
| Nature | Voluntary W3C technical guidelines | Regulatory QMS certification standard |
| Testing | Automated/manual/AT testing, no certification | Internal audits, certification body audits |
| Penalties | Litigation risk, no direct penalties | Certification loss, regulatory enforcement |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about WCAG and ISO 13485
WCAG FAQ
ISO 13485 FAQ
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