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Build safe, compliant medical device software
Enforce your QMS procedures with medical device quality assurance and regulatory compliance software
The Weight of Quality Leadership
Quality leaders carry a tremendous responsibility. They must ensure the safety and compliance of entire products, a task fraught with complexity that goes beyond human comprehension. A lack of understanding of the intricate processes and critical nature of quality assurance can create a significant challenge for these leaders.
Regulatory Compliance and Risk Management
Ensuring patient safety, preventing software errors, preparing for audits, and maintaining up-to-date documentation – all while managing risks across the SDLC – is daunting. New regulatory requirements, such as the FDA’s cybersecurity guidance, necessitate additional resources and time, placing extra burden on manufacturers.
Traceability
Establishing end-to-end traceability between all requirements, risks, specifications, and tests is a daunting task, especially when risks now include critical cybersecurity vulnerabilities.
Operational Inefficiencies and Process Challenges
Significant time can be lost searching for files, dealing with document version confusion, and handling manual, repetitive tasks (like documentation processes) that divert attention from strategic priorities.
Following Established Procedures
Bridging the gap between quality assurance and development teams, each with differing priorities, is a continuous challenge. Ensuring that all teams, especially R&D, follow the established procedures and SOPs can be a persistent struggle.
Resources for QA/RA Leaders
Case Study: How HeartFlow Reduced Complexity by 90% in 10 Weeks with a System of Systems](/content/case-studies/heartflow-case-study/index.html)
White Paper: PCCP Template](/content/white-papers/pccp-template/index.html)
Webinar: Git for IEC 62304](/content/learn/webinars/register/git-for-iec-62304-traceability-for-software-design-unit-testing-and-requirements/index.html)
White Paper: IEC 62304 Compliance Checklist](/content/white-papers/iec-62304-compliance-checklist/index.html)
Blog: PCCP Compliance Guide](/content/blog/pccp-compliance/index.html)
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Blog: Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development](/content/blog/constructive-constraints-enforcement-faster-medical-software-development/index.html)
FDA Compliance Software
Helping quality assurance leaders build audit-ready medical device software
Prevent process deviation
Enforce processes and SOPs directly in preferred DevTools
Get full visibility into compliance processes and reporting
Generate medical device documentation automatically with quality assurance software
Produce a submission-ready DHF automatically
Establish traceability for your medical device software
Prevent dangling items like requirements, risks, and tests directly in project management tools
Generate traceability matrices and other FDA-ready documentation with a few clicks
Streamline change management
Changes are automatically documented through a Part 11-compliant audit trail in Jira
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“The best part of Ketryx is that no one needs to jump from one platform to another. Our developers don’t even need to engage with Ketryx if they’re doing their work in Jira, since Ketryx enforces our QMS there, and Quality can see everything in Ketryx.”
Emre Gültürk
VP of Regulatory Affairs and Quality Systems, HeartFlow
Align Quality with Development