ISO 13485
International standard for medical device quality management systems
GDPR UK
UK regulation for personal data protection and privacy.
Quick Verdict
ISO 13485 provides QMS certification for medical device makers worldwide, while GDPR UK mandates data protection for all UK organizations. Companies adopt ISO 13485 for regulatory market access; GDPR UK to avoid massive fines and ensure compliance.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for medical device QMS
- Regulatory requirements integration into processes
- Design development and process validation mandates
- Post-market surveillance and complaint handling
- Traceability and medical device file requirements
GDPR UK
UK General Data Protection Regulation (UK GDPR)
Key Features
- Seven enforceable data processing principles
- Comprehensive data subject rights framework
- Accountability requiring demonstrable compliance
- Mandatory DPIAs for high-risk processing
- Fines up to 4% global annual turnover
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 13485 Details
What It Is
ISO 13485:2016 specifies requirements for a quality management system (QMS) where organizations demonstrate ability to provide medical devices meeting customer and regulatory requirements. Applicable across device lifecycle stages, it employs a risk-based approach emphasizing documented processes, validation, and traceability for regulatory purposes.
Key Components
- Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Core elements: risk management (ISO 14971), design controls, supplier oversight, post-market surveillance, CAPA.
- Process-based framework with medical device files and record retention.
- Third-party certification via accredited bodies with audits.
Why Organizations Use It
- Facilitates market access (EU MDR, FDA QMSR 2026).
- Mitigates risks of defects, recalls, non-compliance.
- Enhances supply chain control and scalability.
- Builds trust with regulators, partners, stakeholders.
Implementation Overview
- Phased: gap analysis, documentation build, training, validation, internal audits.
- Suits manufacturers, suppliers, distributors globally; 3–36 months by size.
- Involves eQMS, CAPA systems, management reviews for certification readiness.
GDPR UK Details
What It Is
UK GDPR (UK General Data Protection Regulation) is the UK's post-Brexit adaptation of the EU GDPR, a binding regulation enforced by the ICO. It governs personal data processing with a risk-based, accountability-focused approach, applying to UK-established organizations and those targeting UK individuals extraterritorially.
Key Components
- Seven core principles: lawfulness, purpose limitation, minimization, accuracy, storage limitation, security, accountability.
- Data subject rights (access, erasure, portability, objection).
- Controller/processor obligations (RoPAs, DPIAs, contracts).
- No fixed controls; compliance via demonstrable governance, with fines up to 4% global turnover.
Why Organizations Use It
- Mandatory for legal compliance to avoid ICO fines (£17.5M max).
- Enhances risk management, builds trust, enables secure data use.
- Strategic for cross-border ops, AI/profiling, vendor ecosystems.
Implementation Overview
Phased: data mapping, policies, training, DPIAs, audits. Applies universally (size/industry); ongoing, no certification but ICO audits/enforcement.
Key Differences
| Aspect | ISO 13485 | GDPR UK |
|---|---|---|
| Scope | Medical device QMS lifecycle | Personal data processing principles |
| Industry | Medical devices globally | All sectors in UK |
| Nature | Voluntary certification standard | Mandatory legal regulation |
| Testing | Certification body audits | Internal audits, ICO enforcement |
| Penalties | Loss of certification | Fines up to 4% global turnover |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and GDPR UK
ISO 13485 FAQ
GDPR UK FAQ
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