Frequently Asked Questions

How can I use Ketryx for ISO 13485 compliance?

To achieve ISO 13485 compliance, it's necessary to have a comprehensive quality management system (QMS) that covers documentation, risk management, design and development, traceability, and more. These elements form the foundation of an effective quality system.

Managing these critical elements manually can be challenging, which is why Ketryx provides a framework that supports the key processes required by ISO 13485 (as well as IEC 62304 and ISO 14971) and simplifies the necessary workflows. Ketryx helps streamline compliance by offering:

Key Features for ISO 13485 Compliance

• Integrated  Document Control – Our out-of-the-box DHF templates help standardize your quality documentation, ensuring that records are properly maintained, version-controlled, and readily available for audits and reviews.
• Design Controls Management – Define and track design inputs, outputs, verifications, and validations within a structured system.
• Streamlined Risk Management and Change Control – The platform supports structured processes for identifying, managing, and tracking risks and changes, which helps minimize the potential for oversight.
• Comprehensive Traceability and Audit Trails – Ketryx captures detailed audit trails and maintains traceability for all quality-related activities, an essential aspect of regulatory compliance.
• Automated Compliance Workflows – Reduce manual effort with automated approval processes, CAPA tracking, and test result management.
• Seamless Integration with Development Tools – Connect Ketryx with your existing software development and quality management tools to ensure compliance without disrupting workflows.

Elements Covered in the Templated QMS

Ketryx also offers a templated QMS which provides structured procedures and policies that complement Ketryx's automation, including:

• Standard Operating Procedures (SOPs):
  • SOP-001 Records Management
  • SOP-002 Good Documentation Practices
  • SOP-003 Document Control
  • SOP-004 Internal Audit
  • SOP-005 Monitoring and Measurement
  • SOP-006 Training Management
  • SOP-007 Electronic Signatures
  • SOP-008 Quality Agreements
  • SOP-009 Purchasing
  • SOP-010 Deployment and Release Process
  • SOP-011 Design and Development
  • SOP-012 Product Planning
  • SOP-013 Labeling
  • SOP-014 Handling, Storage, and Distribution
  • SOP-015 Production and Process Control
  • SOP-016 Identification and Traceability
  • SOP-017 Incoming Inspection
  • SOP-018 Control of Nonconformances
  • SOP-019 Statistics
  • SOP-020 Installation and Servicing
• Plans and Policies:
  • PLAN-001 Change Management Plan
  • PLAN-002 Application Lifecycle Management Plan
  • PLAN-004 Risk Management Plan
  • POLICY-001 Quality Manual
  • POLICY-002 Software Application Lifecycle Management Policy
  • POLICY-004 Risk Management Policy
  • POLICY-005 Monitoring and Measurement Policy
  • POLICY-006 System Architecture

By integrating these features, Ketryx helps you maintain ISO 13485 compliance efficiently while reducing manual workload and ensuring regulatory readiness.