Jama Connect® for Medical Device & Life Sciences 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 IVDR and MDR medical device directives and regulations
• Agile practices in medical device software development, AAMI TIR45
Areas within the medical device/life sciences space we support, include SaMD, Pharma, Combination Product, Medical Device, Diagnostics (IVD, LDTs, RUO), Biotech, Medical Device Data Systems (MDDS), and more!
Learn about the costly impact of ineffective requirements management on medical device development.
Link high-level requirements to more detailed and sub-system requirements to assure proper validation before release.
• Increase efficiency
• Drive alignment
• Mitigate organizational risk
And even more integrations with other leading software — including automated test solutions— to accelerated and facilitate success across the entire product development lifecycle.
With the rapid innovation in digital health such as clinical web and mobile software applications, the Software as a Medical Device (SaMD) guidance was drafted by the FDA to ensure such software adopt the same general medical device principles to demonstrate safety, effectivity, and performance.
Utilize the native capabilities in the Jama Connect for Digital Health solution to build traceability across development (including requirements, Software of Unknown Provenance (SOUP) / Off the Shelf (OTS), test, and risk management) to foster innovation, enhance product quality, and streamline productivity by letting teams concentrate on the work that counts.
To learn more about Jama Connect for Digital Health, download our solution overview.
“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.”
Protecting our customers’ data is our highest priority. We code with Open Web Application Security Project (OWASP) best practices, host in a secure AWS cloud, perform daily static and dynamic scans, regular PEN tests (third-party), and are SOC 2 Type 2 certified. Jama Software is the only vendor in the requirements management and traceability space that is SOC 2 Type 2 compliant both on the application layer and the data center offerings. Additionally, Jama Connect is the only requirements management solution that is deployed via multi-tenant cloud.
Suitably validated by TÜV SÜD for safety-related development per IEC 62304
Jama Software® codes with OWASP best practices
Jama Connect is SOC2 Type 2 certified in both the server and application
Ensures strong privacy management practices
Transport Layer Security (TLS) ensures data transferred is secured and encrypted
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
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.
• 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
