Accelerate Innovation in Medical Device Development
Free your teams from document-based medical requirements management, streamline your processes to improve outcomes, and spend more time on innovation.
Jama Connect® for Medical Device Development is 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. It is built to include standard medical device frameworks that support key medical device software standards and regulations, including:
• ISO standards for quality and risk management for medical devices (e.g., ISO 13485, ISO 14971)
• IEC standards for medical device lifecycle requirements (e.g., IEC 62304)
• FDA regulations applicable to medical device development (e.g., 21 CFR 820.30 and CFR Part 11)
• EU medical device directives and regulations
• Agile practices in medical device software development, AAMI TIR45
Groundbreaking New Research!
Learn about the costly impact of ineffective requirements management on medical device development.
Ensure Live Traceability™ and alignment across the product development lifecycle to seamlessly connect development solutions and facilitate product success.
7 Out of the Top 10 Global Medical Device Companies Use Jama Connect
Ensure Product Quality and Meet Safety-Critical Standards
Live Traceability
Live Traceability
Link high-level requirements to more detailed and sub-system requirements to assure proper validation before release.
• Increase efficiency
• Drive alignment
• Mitigate organizational risk
Risk Management
Reports
Reviews and Approvals
Verification and Validation
Key Benefits
Align to regulatory requirements quickly
Reduce barriers to medical device compliance
Simplify audit preparation and data exports
Get your product to market faster
Key Features
Out-of-the-box guides for configuration & procedure
Export templates for design history (DHF) & trace reports
Training & consulting to get your teams up and running faster
Standard frameworks aligned to key industry regulations
Jama Connect Integrates with Top-Tier Solutions
And even more integrations with other leading software — including automated test solutions— to accelerated and facilitate success across the entire product development lifecycle.
Software as a Medical Device (SaMD)
With the rapid innovation in digital health such as clinical web and mobile software applications which do not traditionally classify as a “device” due to its lack of custom electromechanics, the Software as a Medical Device guidance (SaMD) was adopted by the FDA along with global regulatory leaders to ensure such software products adopt the same general medical device principles to demonstrate safety, effectivity, and performance.
To learn more about SaMD, watch this information-packed webinar.
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.”
“We all want to spend more time being creative and innovating our products, and Jama Connect gives us more opportunities to do that.”
Accelerate Adoption of Model-Based Systems Engineering (MBSE) for Product Innovation
Learn how Jama Connect Companion MBSE solution provides a path to companies embracing MBSE where the application of collaboration, modeling, and methods reduces time and effort across the product development lifecycle.
• Designing a system using models enables early visualization and simulation, improving stakeholder buy-in and customer satisfaction.
• Enables collaborative, innovative design and maintenance of complex systems.
• Build MBSE organizational maturity with ready-to-use framework and option to connect to additional model tools.
• Creates a textual and relational model across your requirements, architecture, and Verification & Validation data, creating structure and relationship diagrams, to support a more effective model-based systems engineering.
• Makes requirements and all of the data and relationships of the data accessible across the organization.
• Integrates software, hardware, and systems engineering
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.
Included Industry Standards and Regulatory Requirements for Medical Device Development
• ISO 13485:2016 – Standards for quality management requirements for medical devices
• ISO 14971:2019 – The risk management standard for medical devices
• IEC 62304:2006 – Standards for medical device lifecycle requirements and medical device software
• AAMI TIR45 – Agile practices in medical device software development
• FDA Regulations – Several FDA regulations are applicable to medical devices including 21 CFR 820.30 and CFR Part 11
• EU Medical Device Directives – Regulations to sell medical devices in the European union with EU MDR a standard which replaces the current Medical Devices Directive in 2021