ISO Compliance Made Simple
Requify streamlines compliance with ISO 14971, ISO 13485, ISO 9001, and ISO/IEC 27001 through intelligent requirements management, built-in risk analysis, and comprehensive traceability.
Important: Requify supports compliance activities but does not constitute certification to any standard.
Core Capabilities That Support Compliance
Purpose-built features for systematic requirements management and compliance
Risk Analysis & Matrices
Model risks with severity and probability assessments, document controls, and track residual risk levels
- Systematic hazard identification
- Quantitative risk evaluation
- Mandatory review process
End-to-End Traceability
Create bidirectional links across the entire product lifecycle from user needs to verification
- Complete audit trails
- Gap identification
- Compliance demonstration
Suspect Link Detection
Automatically flag when changes impact linked requirements, enabling controlled change management
- Change impact analysis
- Controlled modifications
- Regulatory compliance
Documentation Management
Attach unlimited files to requirements, risks, and tests with version control and access management
- Centralized evidence
- Document traceability
- Audit readiness
Compliance Reporting
Generate comprehensive reports showing compliance status, traceability matrices, and audit evidence
- Automated compliance reports
- Audit preparation
- Regulatory submissions
Team Collaboration
Multi-disciplinary team workflows with role-based access and approval processes
- Cross-functional alignment
- Controlled access
- Workflow automation
Supporting Key ISO Standards
How Requify's features align with critical compliance requirements
ISO 14971
Risk Management for Medical Devices
Systematic approach to risk management throughout the medical device lifecycle
Key Requirements
- Risk management planning and documentation
- Hazard identification and risk estimation
- Risk control measures and residual risk evaluation
- Post-market surveillance and risk review
How Requify Helps
- Built-in risk matrix for hazard analysis and risk estimation
- Link risk controls directly to design requirements
- End-to-end traceability from hazards to mitigations
- Suspect links flag changes that may affect risk assessments
- Document attachments for risk analyses and post-market data
ISO 13485
Quality Management Systems for Medical Devices
Quality management system requirements specific to medical device organizations
Key Requirements
- Design controls with defined inputs and outputs
- Verification and validation planning and execution
- Change control and configuration management
- Document and record control
How Requify Helps
- Trace design inputs to outputs and V&V activities
- Controlled change management with suspect link detection
- Comprehensive documentation attachments
- Audit trails for all requirement changes
- Integration with risk management per ISO 14971
ISO 9001
Quality Management Systems
Universal quality management standard applicable to any organization
Key Requirements
- Customer and stakeholder requirement management
- Process approach and continuous improvement
- Documented information and knowledge management
- Performance evaluation and corrective actions
How Requify Helps
- Centralized stakeholder requirement capture
- Process traceability and relationship mapping
- Document control and version management
- Change impact analysis for continuous improvement
- Evidence collection for performance monitoring
ISO/IEC 27001
Information Security Management Systems
Framework for establishing, implementing, and maintaining information security
Key Requirements
- Information security risk assessment and treatment
- Security control implementation and monitoring
- Incident management and corrective actions
- Supplier relationship and information sharing controls
How Requify Helps
- Security requirement mapping and control traceability
- Risk matrix for information security assessments
- Incident tracking linked to affected requirements
- Document security and access controls
- Change impact analysis for security modifications
Why Requirements Management is Critical for ISO Compliance
Modern compliance requires systematic approaches to managing complex relationships
Audit Efficiency
Quickly demonstrate compliance with comprehensive traceability and evidence
Change Control
Manage modifications systematically with impact analysis and approval workflows
Evidence Collection
Centralize all compliance documentation with secure storage and retrieval
Risk Visibility
Maintain clear visibility into risk levels and control effectiveness
Common Compliance Challenges We Solve
Scattered Documentation
Requirements, risks, and evidence stored across multiple tools and formats
Manual Traceability
Time-consuming manual effort to trace requirements through development
Change Impact Blindness
Difficulty identifying what's affected when requirements change
Inconsistent Risk Management
Ad-hoc risk assessment processes without systematic documentation
Audit Preparation Stress
Weeks of effort to gather evidence and demonstrate compliance
Siloed Teams
Poor communication between engineering, quality, and regulatory teams
The Cost of Poor Requirements Management
of product failures trace back to poor requirements management
higher project costs when requirements issues are found late
of audit findings relate to inadequate documentation and traceability
Ready to Streamline Your Compliance Journey?
Join organizations who have improved requirement traceability across their entire product lifecycle.
Free 14-day trial • No credit card required • Expert compliance consultation included
Getting Started with Compliance in Requify
Simple steps to establish your compliance foundation
Import Your Requirements
Upload existing requirements from spreadsheets, documents, or other tools
Establish Traceability
Link requirements to design elements, tests, and risk controls
Configure Risk Matrix
Set up risk assessment criteria and evaluation workflows
Attach Documentation
Upload supporting documents, test reports, and evidence files
Enable Suspect Links
Activate change impact detection for controlled modifications
Generate Reports
Create compliance reports and traceability matrices for audits
Train Your Team
Onboard stakeholders with role-based access and workflows
Need Help Getting Started?
Our compliance experts can help you configure Requify for your specific ISO requirements and industry needs.
Schedule Consultation