Perform Risk Analysis and Requirements Management on One Platform

Jama Connect helps you identify risks related to a product, trace to mitigations and validate effectiveness. It is integral to ensure that all of your safety-critical products work reliably and as expected, with the lowest chance of causing harm.

As regulatory requirements become more complex and product recalls more common, documenting and controlling risk must be a byproduct of development, not something done after the fact.

Jama Connect allows for risk analysis aligned to industry standards and regulations, treating risk management as an integral part of the product lifecycle process. Your organization can standardize and integrate your risk analysis, evaluation, and management processes in our platform to create a single source of truth for everything risk related.

Our Platform

Develop Quality Products with Integrated Risk Management

best practices

Software Built Upon Best Practices

Jama Connect comes with procedure and configuration guides that minimize setup time and let you begin risk analysis sooner. Conduct tasks such as preliminary hazard analysis (PHA) and failure mode and effects analysis (FMEA) from within the platform.

Proactive

Proactive, Not Reactive, Risk Management

Proactively avoid missed risks and the stress and uncertainty of piecing together risk management files during late stages of product development. With Jama Connect, you can capture, analyze, evaluate and mitigate risks in one central location at each stage of the development process to avoid misses that may require costly late-stage fixes and rework.

collaboration

Enable Cross-Functional Reviews

Cross-functional teams spanning design, software testing and quality can collaborate in real time on risk analyses, even when they are remote with Jama Connect’s Review Center. A Review Moderator keeps teams focused by providing custom messages, supporting context, and real-time feedback to questions, issues or proposed updates.

best practices

Complete Traceability

End-to-end traceability is essential to conclusively demonstrating compliance with industry standards and regulations. Jama Connect has relationship rules that guide and alert users to missing traceability and suspect traceability when requirements or risks are missing or change—ensuring that your test results reflect the latest updates to risks.

Jama Connect

Reduce Risk and Strengthen Requirements

By combining risk analysis and requirements management in a single solution, Jama Connect facilitates building high-quality products with verified and validated requirements to help you comply with applicable regulatory requirements. With Jama Connect, you can:

  • Conduct evolving, up-to-date risk analysis
  • Capture and manage hazards, risk evaluations, mitigations, and verifications
  • View missing and suspect traceability
  • Use live traceability to relate risks to requirements, mitigations and verifications
  • Reinforce all design controls and workflows

Solutions like Jama Connect have come to market and can provide risk management, collaboration, efficiency and regulatory compliance as aspects that strengthen, rather than complicate, each other.”

Frost & Sullivan

Read the Brief

Key Features and Benefits

Make Compliance Straightforward

With Jama Connect, you can lower the risks and strengthen the requirements associated with your safety-critical products for more manageable compliance.

compliance

Aligned to Industry-Standards

The guided risk management item templates in Jama Connect enable the gathering of important data about device design, use cases, and scope so teams can use risk analysis software to evaluate hazards, capture event sequences and perform residual risk evaluations.

requirements management

Easy Export Functionality

Simplify your audits and reliably prove compliance by exporting your risk analysis plan, risk management plan, and risk analysis trace report out of Jama Connect and into commonly used industry formats.

real time collaboration

Real-Time Collaboration

In Jama Connect, collaborators can immediately notify and prioritize critical decisions, pull in required contributors, and reference historical context to ensure that everyone is aligned.

real time collaboration

Early Risk Identification and Mitigation

With risks and requirements in a common system, cross-functional teams can flag risks early on and mitigate accordingly to ensure that safety-critical products meet all requirements and carry the lowest risks to end users.

Solution

Jama Connect for Medical Device Development

A single platform that will help accelerate innovation and manage regulations for medical device development.

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Learn More about Jama Connect

How can we help you? Our team of Jama Connect experts are here to answer any questions and learn how we can help enable your continued success

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