Medical Device

Learn how Jama Connect for Medical Device Development can help teams demonstrate traceability, manage risk analysis, maintain audit trails, export data, streamline compliance and more!

  • Axendia Report: The Costly Impact of Ineffective Requirements Management

    Axendia Report: The Costly Impact of Ineffective Requirements Management

    In this medical device research study from Axendia, a leading Life-Sciences Analyst firm, see how ineffective requirements management can negatively impact budgets, traceability, and V&V activities.

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  • Learn How Jama Accelerates Medical Device Development While Reducing Risk

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  • 2022 Industry Predictions for Medical Device Development

    2022 Industry Predictions for Medical Device Development

    In this eBook, industry experts discuss challenges, disruptors, and tips for standing above the competition in medical device/life science products, systems, and software development.

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  • The Complete Guide to ISO 13485 for Medical Devices

    The Complete Guide to ISO 13485 for Medical Devices

    Read this guide to learn the purpose of ISO 13485 and requirements for adherence, the difference between ISO 13485 and other medical device standards, and get key steps to adoption and certification.

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  • Ensuring FDA Compliance for Your Digital Health Solution49:26

    Ensuring FDA Compliance for Your Digital Health Solution

    Attendees will hear directly from industry leaders Jama Software, MDM Engineering Consultants, & Beanstock Ventures about critical standards and best practices to follow in digital health development.

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  • Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

    Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

    Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA, and 21 CFR Part 820.

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  • Jama Connect for Medical Device Development

    Jama Connect for Medical Device Development

    Learn how using a single platform can help accelerate innovation, maintain consistency and high product quality, and manage ever-changing complex regulations in medical device development.

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  • Jama Connect for Medical Device Development

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  • Your Guide for Selecting a Medical Device Development Platform

    Your Guide for Selecting a Medical Device Development Platform

    Learn what to look for in a medical device development platform to help accelerate the development of safe, high-quality devices while managing ever-shifting complexities and regulations.

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  • How to Execute a Successful Design Review When Building Medical Devices

    How to Execute a Successful Design Review When Building Medical Devices

    Best practices for medical device design reviews, including the six necessary attributes when establishing a framework for planning and implementing a successful design review process.

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  • Experience Jama Connect First Hand with a 30-Day Trial

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  • FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?

    FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?

    Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device development.

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  • 2021 Medical Device Industry Trends and Predictions

    2021 Medical Device Industry Trends and Predictions

    For this information-packed eBook, Jama Software teamed up with Beanstock Ventures to weigh in on trends and predictions for medical device development in the new year and beyond.

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  • The Costly Impact of Ineffective Requirements Management in the Medical Device Industry37:25

    The Costly Impact of Ineffective Requirements Management in the Medical Device Industry

    Join Jama Software and Axendia for our webinar reporting on our groundbreaking research highlighting the costly impact of ineffective requirements management in medical device development.

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  • Requirements Debt: A Medical Product Program Risk

    Requirements Debt: A Medical Product Program Risk

    Read this whitepaper to learn more about the impact of poor requirement definition and traceability on time, scope, and budget – and how reducing requirement debt reduces project risk.

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  • Adopting the EARS Notation to Improve Requirements Engineering

    Adopting the EARS Notation to Improve Requirements Engineering

    In this paper, we examine how and why the Easy Approach to Requirements Engineering Syntax (EARS) notation enables cross-team collaboration, improves product requirements, and reduces project risk.

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  • The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

    The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

    In this whitepaper, experts from Beanstock Ventures cover the emergence of Software as a Medical Device (SaMD), potential challenges for digital health technology, and recommendations to address them.

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  • Medical Device Startup, Proprio, Chooses Jama Connect® to Drive Innovation

    Medical Device Startup, Proprio, Chooses Jama Connect® to Drive Innovation

    Read this customer story to learn more about the value of a requirements-driven product development process and the limitations of the typical Quality Management System (QMS).

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  • Celebrating the Innovative Teams We've Empowered

    Celebrating the Innovative Teams We've Empowered

    Get a brief overview of four Jama Software customer stories. Rimac car manufacturer, Jones Lang LaSalle Incorporated (JLL), Deloitte, and RBC Medical Innovations each faced unique challenges.

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  • Streamlining Complex Systems Development for Faster Compliance

    Streamlining Complex Systems Development for Faster Compliance

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  • Jama Connect™ for Medical Device Development Demo10:22

    Jama Connect™ for Medical Device Development Demo

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  • What the New Medical Device Regulations (EU MDR) Mean for You

    What the New Medical Device Regulations (EU MDR) Mean for You

    The new Medical Device Regulation (EU MDR) addresses software as a medical device (SaMD), as well as other products. Here, we cover the new regulations and highlight the most important changes.

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  • Validation Kit for Medical Device & Drug Development Teams

    Validation Kit for Medical Device & Drug Development Teams

    The Jama Connect Validation Kit for Medical Device and Drug Development teams is designed to reduce the time required for validation, define safety-critical workflows, and streamline your process.

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