Jama for Medical Devices

Achieve compliance, improve efficiency and maintain alignment with Jama’s requirements management software.

Join us for a webinar on Dec 14, 2016: Live Traceability: The Golden Key to Proof of Compliance @ 8:00AM PST

Review and approve robust, contextual information across stakeholders, engineers and partners.

Build it right and achieve compliance

When you make high-stakes products, you need confidence your teams are adhering to compliance or quality processes.

Jama lets teams focus on making great medical devices that drive value and improve quality of life. With Jama configured to your workflows and best practices, teams are empowered to spend more time on product development and less time on managing compliance processes and documentation.

Standards and Regulations we support: 21CFR820, 21CFR11, ISO 13485, ISO 14971, IEC 62304, IEC 61508

Conduct reviews and approvals

Maintain the chain of approval and increase stakeholder participation. Within Jama, tie electronic signatures to specific reviews or baselines in compliance with 21 CFR Part 11. Learn more about Reviews & Approvals.

Design verification and validation

Seamlessly manage V-model traceability including test cases used for verification and validation, and provide evidence to comply with government regulations and standards, like 21 CFR Part 820. Read more about Test Management.

Maintain audit trails with reports

Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including time-stamps and associated users. See more on Reporting.

By 2019, 25% of supply chain organizations collaborating on digital products and services will experience at least one product failure due to software defects and related cyber risks.

Janet Suleski, Gartner Predicts 2016: Digital Business Will Disrupt Product Design, Manufacturing and PLM, 16 November 2015
 
Construct intuitive rules for traceability.

Mitigate risk, increase efficiency and drive alignment with traceability

Today, it’s more difficult to innovate while ensuring quality. The rise of software-driven medical devices and the Internet of Things has increased development complexity.

The increased complexity introduces risk to teams using outdated process, like manual traceability. Jama provides intuitive end-to-end linking — including and all related changes, decisions and people — from upstream market and product requirements to test cases and defect tracking.

Trace requirements end-to-end

Link and decompose program-level capability requirements and operational requirements to system requirements, and then down to lower-level software and hardware requirements. Learn more about Coverage.

See the impact of change quickly

Fine-grained impact analysis provides instant data insights. Use the analysis to make informed decisions as requirements evolve during long development cycles or due to shifts in technology.Take a look at Workflow Mapping.

Manage risk analysis

Create a customizable view with calculated fields to manage your risk analysis process within Jama. Ensure that your product is safe and meets regulatory standards. Read more about Calculated Fields.

See it in action

This 5-minute overview illustrates how to use Jama to build a complex medical device that contains both hardware and software components.

Try Jama out for 30 days using the same dataset by activating your free trial.

Try Jama Now

 

Featured Resources

Risk Management for Modern Medical Device Makers

Read the White Paper

SANS Health Care Cyberthreat Report

Read the Report

Streamlining Complex Systems Development for Faster Compliance

Read the White Paper