Medical Device & Life Sciences
Learn how Jama Connect® for Medical Device & Life Sciences Product Development can help teams demonstrate traceability, manage risk analysis, maintain audit trails, export data, streamline compliance and more!
Understanding Integrated Risk Management for Medical Devices
In this paper, industry experts share best practices for integrated risk management, how to integrate risk-based thinking into product development cycles, and the importance of traceability.
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FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?
Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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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Jama Connect® for Medical Device Development Datasheet
Download this datasheet to learn how Jama Connect for Medical Device Development accelerates innovation in medical device development while adhering to industry regulations.
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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.
Complying with FDA Design Control Requirements Using RM Principles
Join our webinar to learn more about how a good requirements management process helps facilitate compliance with FDA design control requirements.
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)
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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Jama Connect™ for Medical Device Development Demo
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.
Application of Risk Analysis Techniques in Jama Connect® 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.
Microsurgical Robot Developer, Microsure, Leverages Jama Connect® to Ease the Path to Compliance and Speed Time to Market
In this customer story, we cover how Microsure leverages Jama Connect® to involve all team members in development, efficiently manage change, and quickly provide necessary regulatory documentation.
2023 Medical Device Product Development Predictions
In this eBook, subject matter experts weigh in on medical device product development trends they’re anticipating in 2023 and beyond.
Your Guide to the Verifying Accurate Leading-edge IVCT Development (VALID) Act
In this comprehensive guide to the VALID Act, we examine the provisions and implications of the VALID Act and how it applies to product development and risk management for medical devices.
Jama Connect® Features in Five: Risk Management for Medical Device
In this Features in Five video, we do go beyond the promised five-minute format to include an information-packed session on how risk management integrates with Jama Connect for Medical Device.
The Complete Guide to ISO/IEC/IEEE 15288:2015 — Systems and Software Engineering and Lifecycle Processes
In this guide, we take a comprehensive look at ISO/IEC/IEEE 15288:2015 goals, standards, and tools that help achieve compliance.
A Guide to Good Systems Engineering Best Practices: The Basics and Beyond
In this eBook, we discuss the fundamentals of systems engineering best practices, the “V” model, we cover the characteristics of good systems engineering, and lessons learned.
Understanding Integrated Risk Management for Medical Device
In this webinar, experts will walk through how to take a comprehensive and integrated approach to risk management for medical device development – and the benefits.
Vave Health Migrates to Jama Connect® to Accelerate Development and FDA Clearance
See why Vave Health chose Jama Connect® to automate and streamline processes in order to maintain efficient release cadences, manage change, and ensure full verification and validation (V&V) coverage.
An Introduction to Research Use Only (RUO)
In this eBook, we provide an overview of the Research Use Only (RUO) label, how it differs from similar, adjacent labels, its appropriate use, and the consequences of mislabeling products RUO.
The New EU In Vitro Diagnostic Regulation: What's Changing and What You Need to Know
In this whitepaper, we’ll discuss how emerging In-Vitro Diagnostics (IVDs) will be developed, managed, and regulated in the EU and beyond according to the new In Vitro Diagnostic Regulation (IVDR).