White Paper
Ketryx Quality Practices: How Ketryx Builds, Validates, and Governs Its Own Platform
How Ketryx builds and maintains the platform under a certified quality system aligned with ISO 13485, IEC 62304, and ISO 14971 — so your supplier qualification evidence is already audit-ready.
The Ketryx Quality Practices guide explains how we build and maintain the Ketryx Platform under a certified quality system aligned with ISO 13485, IEC 62304, and ISO 14971. Ketryx builds software that regulated companies use to develop and release their own products. That places quality at the center of everything we do. Our customers in medical devices, diagnostics, pharma, and digital health are held to demanding standards, and the platform they rely on has to meet the same bar. For quality engineers, regulatory affairs leads, and IT auditors, it means faster supplier qualification: the evidence is already assembled, documented, and ready to reference in an audit.
What You'll Learn:
- How Ketryx validates the platform continuously, and what's inside the validation package.
- How risk-focused change control, configuration management, and Part 11 electronic signatures govern every production release.
- What our certifications cover (ISO 13485, IEC 62304, ISO 14971, ISO 27001, SOC 2 Type II) and how to use them in supplier qualification.
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