ISO 13485
International standard for medical device quality management systems
MAS TRM
Singapore guidelines for financial technology risk management
Quick Verdict
ISO 13485 ensures medical device quality compliance globally via certification, while MAS TRM mandates technology risk governance for Singapore FIs through supervisory enforcement. Manufacturers seek ISO 13485 for market access; banks adopt TRM to avoid fines and ensure resilience.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS tailored for medical devices
- Regulatory compliance and lifecycle coverage
- Strict documentation, traceability, and validation
- Post-market surveillance and complaint handling
- Supplier controls and outsourcing oversight
MAS TRM
MAS Technology Risk Management Guidelines 2021
Key Features
- Board and senior management accountability for tech risks
- Proportionality based on FI risk profile and complexity
- Third-party risk management beyond formal outsourcing
- Layered cyber defenses with annual pen testing
- End-to-end lifecycle from governance to IT audit
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 titled "Medical devices — Quality management systems — Requirements for regulatory purposes." It specifies requirements for a risk-based QMS enabling organizations to consistently meet customer and regulatory demands across the medical device lifecycle, from design to post-market activities.
Key Components
- Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, traceability, validation, risk management (linked to ISO 14971), supplier controls, and post-market surveillance.
- Built on process approach; requires certification via accredited bodies with stage audits and surveillance.
Why Organizations Use It
- Ensures regulatory alignment (EU MDR, FDA QMSR 2026), reduces compliance risks, enables market access.
- Drives operational excellence, cost savings via defect reduction, builds stakeholder trust.
- Provides competitive edge through certification signaling maturity.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers, distributors globally; scalable for SMEs to enterprises.
- Involves eQMS adoption, CAPA, internal audits; certification every 3 years.
MAS TRM Details
What It Is
MAS Technology Risk Management (TRM) Guidelines (January 2021) are supervisory guidance from the Monetary Authority of Singapore for financial institutions. They provide a principles-based framework for managing technology and cyber risks, emphasizing governance, controls, and resilience to protect confidentiality, integrity, and availability (CIA). The risk-proportional approach tailors implementation to an FI's complexity and exposure.
Key Components
- 15 sections covering governance, risk frameworks, secure development, operations, resilience, access controls, cryptography, cyber defense, testing, and audit.
- Synthesized into 12 core principles like board accountability, asset classification, third-party oversight, and layered defenses.
- No fixed controls; focuses on outcomes with continuous improvement.
- Compliance via supervisory review, no formal certification.
Why Organizations Use It
- Meets MAS supervisory expectations to avoid fines/enforcement.
- Enhances cyber resilience, operational stability, customer trust.
- Supports digital transformation while managing third-party/API risks.
- Builds board-level risk metrics for strategic decisions.
Implementation Overview
- Phased: governance setup, asset inventory, control design, testing, monitoring.
- Applies to all Singapore-supervised FIs; proportional by size/risk.
- Involves policies, training, DR tests; independent audit required.
Key Differences
| Aspect | ISO 13485 | MAS TRM |
|---|---|---|
| Scope | Medical device QMS lifecycle from design to post-market | Financial sector technology/cyber risk governance and controls |
| Industry | Medical devices and suppliers globally | Singapore financial institutions (banks, insurers, fintechs) |
| Nature | Voluntary international certification standard | Supervisory guidelines with enforcement consideration |
| Testing | Process validation, internal audits, certification audits | Annual pen testing for internet systems, vulnerability assessments |
| Penalties | Loss of certification, market access barriers | Fines, license revocation, executive prohibitions |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and MAS TRM
ISO 13485 FAQ
MAS TRM FAQ
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