Jama Connect for Medical Device Development

A single powerful platform for medical device teams to manage design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations while accelerating time to market.

Key Benefits

Align to regulatory requirements quickly

Reduce barriers to compliance

Simplify audit preparation and data exports

Get your product to market faster

Key Features

Out-of-the-box configuration and procedure guides

Export templates for design history files (DHF) & trace reports

Training and consulting to get your teams up and running faster

Standard frameworks aligned to key industry regulations

7 Out of the Top 10 Global Medical Device Companies Use Jama Connect

Abbott
Abiomed
Grifols
Ossur
Medtronic
Boston Scientific

Accelerate Development with a Solution Aligned to Regulatory Requirements

Built to include standard medical device frameworks that support key industry standards and regulations.

  • ISO standards for quality and risk management for medical devices
  • IEC standards for medical device lifecycle requirements
  • AAMI TIR45 standard for Agile practices in medical device software development
  • FDA Regulations applicable to medical device development
  • EU Medical Device Directives and regulations
Additional Requirements
Requirements and Regulations

Increase Efficiency and Innovation in Medical Device Development

“Jama Connect frees us up to focus on the design of the product, not the logistics of the work that needs to be done. We are able to spend our time more effectively — helping our customers.”

Scott Britt
Systems Engineering Manager

“We all want to spend more time being creative and innovating our products, and Jama Connect gives us more opportunities to do that.”

Lars Jensen
Product Quality Assurance Manager

Improve Product Quality and Meet Regulatory Requirements

Live Traceability

Link high-level requirements to more detailed and sub-system requirements to ensure proper validation before release.

  • Increase efficiency
  • Drive alignment
  • Mitigate organizational risk

Risk Management

Establish a risk management framework to ensure quality and minimize design changes.

  • Align with ISO 14971:2019
  • Mitigate risk earlier in development
  • Support the path to regulatory compliance

Reports

Track all changes to information within the system with customizable, real-time reporting and baselining.

  • Maintain audit trails
  • Track all changes
  • Include timestamps and associated users
  • Export data easily for Design History File (DHF), trace reports and other uses

Compliant Reviews and Approvals

Achieve compliance with FDA 21 CFR Part 11 when you combine with your organization’s quality process.

  • Increase participation in the review process
  • Provide visibility sooner in the review process
  • Generate approval-ready content for e-signature faster

Design Verification and Validation

Seamlessly manage traceability to test cases used for verification and validation.

  • Provide evidence to comply with regulations and standards, like 21 CFR Part 820.30
  • Manage traceability to test cases used for verification and validation

Jama Connect integrates with top-tier solutions

Testrail Tricentis Jira

And even more integrations with other leading software — including automated test solutions— to accelerated and facilitate success across the entire product development lifecycle.

Learn More

Jama Connect Integrations

See Jama Connect in Action

A demo is an easy way to learn more about Jama Connect for Medical Device Development. See key features in action and understand how medical device teams use the solution to support their development process. This demonstration provides a detailed overview of the solution and will take about 10 minutes of your time to complete.


Watch platform deep dive

Jama Connect Integrations

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.

Talk to an expert