Accelerate the Development of Safe and Effective Medical Devices & Life Science Products with Jama Connect

In the medical device & life sciences industries, the transformation from hardware-focused devices to diverse products driven by software — in combination with hardware and bioware — is reshaping the tools and processes by which devices and related products are developed. Jama Connect for medical device requirements management is purpose-built to reduce the effort required to achieve regulatory compliance by managing design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations, and accelerating time to market.

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Address Medical Device & Life Science Product Development Challenges with Jama Connect

With Jama Connect You Can:

Efficiently manage requirements, risks, verification, and validation through Live Traceability™
Quickly align systems engineering disciplines across hardware, software, and bioware product development teams
Simplify regulatory submissions and compliance with industry standards

Support Multiple and Hybrid Product Development Processes (PDP)

Jama Connect provides a flexible solution to manage all of your product development methods.

Manage Requirements, Risks, Verification, and Validation for Hardware, Software, and Bioware Development

Jama Connect offers a comprehensive solution for simplifying the product development process across the device, product, system and software lifecycle.

Efficiently Handle Iterative Review Cycles, Baseline Management, and Audit-Ready Documentation

Jama Connect streamlines review cycles and document creation for your design history file/technical file to complement your quality management system.

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Jama Connect is the platform choice for 8 of the top 10 global medical device companies and 5 of the top 10 life sciences companies.

“Jama Connect’s automation allows us to efficiently manage each release. The tool allows us to reduce manual processes involved in generating traceability and focus our efforts on reviews of the trace matrix. Efficiency and speed are critical in managing our software cadence and to be competitive in the marketplace.”

Sandhya MitnalaHead of Quality and Regulatory –Read Customer Story

“With Review Center, we review things more incrementally, and we can catch changes, or things to fix, very early in the process. So, the cost at the end is less.”

Carmen Pazos Diagnostic Divisions R&D, Instruments Sr Manager –Read Customer Story

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Simplify Regulatory Submissions and Audit Preparations with Jama Connect

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:

Regulatory Agencies: FDA 21 CFR 820.30, 21 CFR 11, EU MDR, EU IVDR
Quality Systems: ISO 13485
Risk Management Process and Methods: ISO 14971, IEC 60812
Medical Software Development: IEC 62304, AAMI TIR 45 and SW 96
Human Factors and Usability Engineering: HE 75, IEC 62366

Areas within the medical device/life sciences space Jama Software supports include Medical Devices, Diagnostics (IVDs, LDTs, RUOs), Medical Device Software, Pharmaceuticals, Life Sciences, and more!

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Features to Ensure Product Quality and Meet Safety-Critical Standards

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

Requirements Management

Risk Management

Verification and Validation

Reuse & Sync

Reviews and Approvals

Documentation

Design History File / Technical File

Understanding Integrated Risk Management for Medical Devices

Medical device companies continually assess potential risks to individuals in order to enhance safety and comply with regulatory requirements. Risk management in the context of ISO 14971 is an integrated process that not only includes teams in product development, quality, but also many other parts of an organization.

Download this free whitepaper to learn more about:

Best practices for integrated risk management
How to integrate risk-based thinking into product development cycles
The importance of having end-to-end traceability to improve risk management

>> Download Free Whitepaper

Jama Connect is the Leader in Security, SLAs, High Availability, Touchless Upgrades, and Disaster Recovery

Jama Software is the only vendor in the space that offers the following: SOC 2 Type 2 certified application and data center (others data center only), SLAs above 99% (others at 95% or lower), touchless upgrades (others require your IT to manually update hosted app), high availability SLA (others don’t offer), disaster recovery SLA (others don’t offer).

Suitably validated by TÜV SÜD for safety-related development

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

Effective Strategies and Solutions for Successful SaMD Project Execution webinar image

Focus on Development Instead of Documentation with Jama Connect for Software as a Medical Device

Software as a Medical Device (SaMD) often involves a struggle to balance demanding documentation with highly iterative software development cycles under tight deadlines. Jama Connect for SaMD helps alleviate the burden of documentation to allow teams to focus on innovation and the efficient development of medical software products that are safe, effective, and compliant.

Download this free webinar to learn more about:

The new SaMD Framework, which features ISO-aligned document templates and customization capabilities and see it in action.
Variant Management in Jama Connect, the key concepts required, and how it can revolutionize your workflow.
Insights into the nuances of navigating complex medical device software projects.
A brief exploration of the impact of US and EU regulations shaping the software landscape.

>> Download Free Webinar

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See Jama Connect in Action!

Our Jama Connect experts are ready to guide you through a personalized demo, answer your questions, and show you how Jama Connect can help you identify risks, improve cross-team collaboration, and drive faster time to market.