What It Is

Regulation (EU) 2016/679, known as the General Data Protection Regulation (GDPR), is a directly applicable EU regulation. Its primary purpose is protecting natural persons' personal data privacy while enabling free data movement in the Digital Single Market. It employs a risk-based approach centered on accountability, requiring organizations to demonstrate compliance.

Key Components

• Seven core principles: lawfulness, fairness, purpose limitation, minimization, accuracy, storage limitation, integrity/confidentiality.
• Enhanced data subject rights: access, rectification, erasure, portability, objection.
• Obligations include Records of Processing Activities (ROPA), Data Protection Impact Assessments (DPIAs), Data Protection Officers (DPOs), 72-hour breach notifications.
• No formal certification; compliance via accountability to supervisory authorities.

Why Organizations Use It

• Mandatory for any processing EU residents' data, avoiding fines up to 4% global turnover.
• Builds stakeholder trust, manages risks from breaches/data misuse.
• Establishes global benchmark (Brussels Effect), enhancing reputation/competitiveness.

Implementation Overview

Gap analysis, policy updates, DPO appointment, staff training, vendor contracts. Applies universally to controllers/processors handling EU data, any size/location. Subject to DPA audits/enforcement.

What It Is

ISO 13485:2016, titled "Medical devices — Quality management systems — Requirements for regulatory purposes," is a certifiable international standard. It establishes a risk-based QMS framework for organizations across the medical device lifecycle, from design to post-market activities, ensuring devices meet customer and regulatory requirements through documented processes, validation, and traceability.

Key Components

• Clauses 4–8 cover QMS/documentation, management responsibility, resources, product realization, and measurement/improvement.
• Emphasizes medical device files, risk management (per ISO 14971), supplier controls, process validation, and post-market surveillance.
• Built on process approach; requires certification by accredited bodies with audits.

Why Organizations Use It

• Aligns with EU MDR, upcoming FDA QMSR (2026), enabling market access.
• Reduces risks like recalls via robust controls; builds stakeholder trust.
• Drives efficiency, scalability, and competitive edge in regulated markets.

Implementation Overview

• Phased: gap analysis, documentation, training, validation, internal audits.
• Applies to manufacturers, suppliers globally; 9–18 months typical for mid-size firms.
• Involves certification audits (Stage 1/2, surveillance).