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Quality Assurance and Regulatory Affairs

# Build safe, compliant medical device software

## Enforce your QMS procedures with medical device quality assurance and regulatory compliance software

The Weight of Quality Leadership

## Navigating Complexity as Quality Assurance and Regulatory Affairs Leaders

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

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Case Study\\
**How HeartFlow Reduced Complexity by 90% in 10 Weeks with a System of Systems**](https://www.ketryx.com/case-studies/heartflow-case-study)

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White Paper\\
**PCCP Template**](https://www.ketryx.com/white-papers/pccp-template)

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Webinar\\
**Git for IEC 62304**](https://www.ketryx.com/learn/webinars/register/git-for-iec-62304-traceability-for-software-design-unit-testing-and-requirements)

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White Paper\\
**IEC 62304 Compliance Checklist**](https://www.ketryx.com/white-papers/iec-62304-compliance-checklist)

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Blog\\
**PCCP Compliance Guide**](https://www.ketryx.com/blog/pccp-compliance)

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Blog\\
**Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development**](https://www.ketryx.com/blog/constructive-constraints-enforcement-faster-medical-software-development)

FDA Compliance Software

## Helping quality assurance leaders build audit-ready medical device software

### Prevent process deviation

[Explore Enforcement](https://www.ketryx.com/capabilities/enforcement)

[Enforce processes and SOPs directly in preferred DevTools](https://www.ketryx.com/function/quality#)

[Unify development and quality processes with intelligent guardrails, like compliance checks in Jira and GitHub](https://www.ketryx.com/function/quality#)

[Get full visibility into compliance processes and reporting](https://www.ketryx.com/function/quality#)

### Generate medical device documentation automatically with quality assurance software

[See Documentation](https://www.ketryx.com/capabilities/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](https://www.ketryx.com/function/quality#)

[Produce a submission-ready DHF automatically](https://www.ketryx.com/function/quality#)

### Establish traceability for your medical device software

[Explore Traceability](https://www.ketryx.com/capabilities/traceability)

[Prevent dangling items like requirements, risks, and tests directly in project management tools](https://www.ketryx.com/function/quality#)

[Generate traceability matrices and other FDA-ready documentation with a few clicks](https://www.ketryx.com/function/quality#)

[Quickly identify coverage gaps and see how all risks, specifications, tests, and requirements are connected across the SDLC](https://www.ketryx.com/function/quality#)

### Streamline change management

[See how it works](https://www.ketryx.com/product)

[Changes are automatically documented through a Part 11-compliant audit trail in Jira](https://www.ketryx.com/function/quality#)

[Ketryx makes it easier to isolate and mitigate post-market risks, reducing the possibility of recalls and patient harm](https://www.ketryx.com/function/quality#)

[No need to duplicate work, like recording changes across multiple documents, so your team can focus on more strategic priorities and less tedious work](https://www.ketryx.com/function/quality#)

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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

## Ketryx bridges the gap between R&D and Quality for higher productivity and enhanced collaboration.

[Watch webinar](https://www.ketryx.com/function/quality#)

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