Build safe, compliant medical device software
Enforce your QMS procedures with medical device quality assurance and regulatory compliance software
Navigating Complexity as Quality Assurance and Regulatory Affairs 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
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Helping quality assurance leaders build audit-ready medical device software
Generate medical device documentation automatically with quality assurance software
Establish traceability for your medical device software
Streamline change management
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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.”
Ketryx bridges the gap between R&D and Quality for higher productivity and enhanced collaboration.
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