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!
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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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Learn How Jama Accelerates Medical Device Development While Reducing Risk
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FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?
Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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.
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54:38WatchComplying 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.
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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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49:26WatchEnsuring 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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10:22WatchJama Connect™ for Medical Device Development Demo
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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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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.
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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.
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5:17WatchJama Connect® Features in Five: Using Jama Connect with a Quality Management System (QMS) for Medical Device & Life Sciences
In this Features in Five video, Steven Pink, Senior Solutions Architect at Jama Software®, provides insight into how Jama Connect® is commonly used in the context of medical device quality management
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5:17WatchJama Connect® Features in Five: Using Jama Connect with a Quality Management System (QMS) for Medical Device & Life Sciences
In this video, learn how Jama Connect is commonly used in the context of a medical device Quality Management System (QMS)
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46:50WatchAn Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)
In this webinar, learn about observations and future considerations for medical device manufacturers in the EU market.
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Jama Connect® Cloud Deployment Options
In this datasheet, we’ll detail Jama Software’s scalable, highly available, secured environment to meet today’s complex development challenges and rigorous security standards.
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Jama Connect® Validated Cloud Package for Medical Device and Life Sciences
In this datasheet, we cover the Jama Connect® Validated Cloud Package (an AWS cloud offering) and discuss what’s included, the benefits, and what resources are available to enable validation.
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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.
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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.
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7:59WatchJama 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.
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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.
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