Medical Device Quality Assurance & Regulatory Affairs (QA/RA) Software - Ketryx
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
White Paper
PCCP Template
Webinar
Git for IEC 62304
White Paper
IEC 62304 Compliance Checklist
Blog
PCCP Compliance Guide
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Blog
Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
Helping quality assurance leaders build audit-ready medical device software
Prevent process deviation
Explore Enforcement
Enforce processes and SOPs directly in preferred DevTools
Unify development and quality processes with intelligent guardrails, like compliance checks in Jira and GitHub
Get full visibility into compliance processes and reporting
Generate medical device documentation automatically with quality assurance software
See Documentation
Ketryx documents work automatically from DevTools, eliminating manual, error-prone cutting and pasting, significantly reducing the possibility of error, mistakes, recalls, product defects and patient harm
Produce a submission-ready DHF automatically
Establish traceability for your medical device software
Explore Traceability
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
Quickly identify coverage gaps and see how all risks, specifications, tests, and requirements are connected across the SDLC
Ketryx AI makes your review process stronger
Explore Ketryx Assistant
Run nightly quality review agents that catch gaps you'd otherwise find at release, so your team can focus review time on judgment calls, not manual scanning
Surface conflicting requirements, test coverage gaps, and missing risk controls up to 90% faster, giving you more time for the risk management work that actually requires your expertise
Every AI-generated finding requires your review and approval through a Part 11-compliant workflow, so you stay in control of every decision
Streamline change management
See how it works
Changes are automatically documented through a Part 11-compliant audit trail in Jira
Ketryx makes it easier to isolate and mitigate post-market risks, reducing the possibility of recalls and patient harm
No need to duplicate work, like recording changes across multiple documents, so your team can focus on more strategic priorities and less tedious work
Instant answers, wherever your team works
Learn about MCP
Ask plain-language questions about traceability gaps, unverified risk controls, and missing test cases, and get verifiable answers in seconds from Claude, Copilot, or any AI tool your team already uses
Answers are grounded in your live Ketryx data, not a generic AI response, so you can act on them with confidence
Walk into any audit knowing you can answer hard questions on the spot
“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