Aignostics - Ketryx

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How Aignostics is Accelerating AI Development in Medicine with Ketryx

Aignostics is a global artificial intelligence (AI) company that turns complex multi-modal pathology data into transformative insights. With an expanding portfolio of AI-powered pathology products, Aignostics needed a streamlined, integrated solution to support their regulated software development processes and ISO 13485 certification. By transitioning to Ketryx, Aignostics was able to cut their release time down to three months while staying compliant.

Impact

3 months

Accelerated release cycle time

13485

ISO certification

$34 million

Series B funding

Industry

Life Science

Device Type

AI, Pathology

Tech Stack

Jira, GitHub

Customer pain points

Burdensome copying and pasting from Jira to the ALM

Disconnected Tooling: Existing processes using the previous ALM and Jira created two technically disconnected environments—one for engineering and one for quality/regulatory—which duplicated maintenance efforts.
Burdensome Documentation: Manual processes for traceability and documentation required copying and pasting from Jira to the ALM.
Limited Scalability: Maintaining traceability across a growing team and complex AI product suite with a system of systems approach became increasingly challenging.

Ketryx solution

AI-first interoperability between developer tools

Documentation from Systems of Work: Evidence of validation is generated as a result of development work, and not as an additional process.
Jira Integration: Modern approach to Jira integration, including built-in traceability in Jira, lets developers use their preferred tooling.
Git Integration: Ability to link software specifications and tests directly from Git repositories keeps documentation close to the code, increases usability, and eliminates duplication.
Intuitive Usability and Validation: Modern UI, GxP validation, and clear documentation made it easier for teams new to regulated software development to build compliant software fast.
Strong Customer Support: A customer-first mindset and rapid issue resolution from Ketryx’s team of experts stood out compared to competitors.
Automated SBOM: Support for SBOM generation and ongoing vulnerability management was vital to strengthen cybersecurity posture.
Milestone-Based Approvals: Milestones feature and ability to do approvals in Jira simplified and sped up the design review process.
System of Systems Approach: Ketryx enabled component reuse and versioning across the product suite.
Customizable Document Generation: Ketryx automates customized PDF exports for audits and regulatory reporting.
Data Management: Ability to manage AI requirements and performance evaluations in Jira with Ketryx integration streamlined data management practices.

Business outcomes

Scaling AI-powered product growth

Accelerated Development: Reduced the cycle time to achieve their first internal release for a new product to 3 months, while in parallel introducing Ketryx across multiple teams.
Embedded Traceability and End-To-End Risk Management : Aignostics improved end-to-end traceability with a clear requirements and risk traceability matrix integrated directly within existing tools like Jira.
Documentation Efficiency: Eliminated manual copying and pasting across tools, saving an estimated several months of work annually.
Simplified Approval Workflows: Design reviews and milestone approvals are now managed seamlessly within Ketryx, aligning with ISO 13485 requirements.
Unified QMS: As QMS is updated to reflect EU and FDA AI and cybersecurity standards, Ketryx workflows align accordingly to ensure compliance.
Easier Compliance Audits: ISO 13485 audit requirements related to software development and risk management are managed more easily in Ketryx because of the predefined software development workflow that reflects requirements from the IEC 62304 and ISO 14971 standards.
Increased Developer Satisfaction and Speed: Engineers prefer Ketryx over the previous solution, citing ease of use and reduced documentation burden.

"Ketryx is becoming an intrinsic part of every piece of software we build. It’s not another tool we have to use on the side to be compliant with standards; it’s just a natural way of developing high-quality software with excellence."

Helmut Hoffer von Ankershoffen

Senior VP Product and Engineering

"Ketryx allowed us to simplify a few process steps, like approvals and design reviews. We have an overall better process compliance with Ketryx, and we rely very much on the predefined workflow that is equivalent to ISO 62304. That helps us because we don't have to invest so much effort in configuring that ourselves."

Frank Münzinger

Quality Manager

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