Medical Device
Accelerate medical device development while reducing risk.
Jama for Medical Device Development
Jama Software helps medical device developers manage requirements, risk, testing and project volatility to ease the path to compliance. Free your teams from document-based requirements management, streamline processes and spend more time on innovation. Read the brief for more information.
Gain Confidence in Your Compliance
Manage complex product requirements from idea through development, launch and iteration.
- Align your development process to your regulatory strategy to achieve compliance for Class II and Class III medical devices
- Use detailed impact analysis to inform decisions as requirements evolve
- Manage design controls, build design history files (DHF), and adhere to regulatory requirements for relevant parts of FDA CFR Part 820.30, ISO 13485:2016, and EU MDR
- Store everything in Jama Connect, so regulatory submissions and audit preparations become a straightforward process
Conduct reviews and approvals
Increase early stakeholder visibility and participation in reviews to generate approval-ready content for e-signature. When combined with your organization’s quality process, this helps achieve compliance with 21 CFR Part 11.
Verification and validation
Seamlessly manage traceability, including the test cases you use for verification and validation. When aligned to your organization’s quality process, you can also provide evidence to comply with FDA standards such as 21 CFR Part 820.
Maintain audit trails with reports
Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including timestamps and associated users.
Jama Connect Risk Management Center
Mitigate Risk Early and Often
Analyzing risk is a critical part of medical device development. The Jama Connect Risk Management Center enables medical device developers to mitigate risk within the platform itself, in accordance with ISO 14971 and IEC 60812.
- Participate in risk management techniques including Preliminary Hazard Analysis (PHA) and FMEA
- Apply risk plan templates
- Link verifications back to requirements
- Export analyses for sign-off
- Work with live data to ensure risks are properly mitigated
- Get expert risk training for your team with Risk Management Services
Medical Device Services
Streamline Your Development and Path to Compliance
Tightly aligned to ISO 13485:2016 & 21 CFR 820.30, Jama’s Medical Device Services facilitate the path to regulatory compliance and ensures teams get up and running quickly.
Out of the box framework for doing medical device development in Jama Connect.
User training tailored to your specific process.
Templates to produce required documentation for your DHF.
Consulting to tailor the solution to your unique needs.
Ready to Get Started with Jama Connect?
Learn more about how Jama Connect can help ease the path to compliance with integrated risk management.
Paper
Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971
This paper describes the main clauses of ISO 14971, the FDA’s mandatory standard for risk assessment in medical devices, and outlines how Jama Connect™ gives medical device developers a comprehensive way to manage risk and requirements throughout the product development lifecycle.
