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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FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?
Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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 & Life Sciences Development Datasheet
Download this datasheet to learn how Jama Connect for Medical Device & Life Sciences 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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Jama Connect for Digital Health Solution Overview
See how Jama Connect® for Digital Health helps medical device development teams accelerate innovation in digital health solutions while adhering to industry regulations.
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What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
Read this comprehensive guide to understanding ANSI/AAMI SW96:2023 and mitigating security risks in medical device development.
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Manage Risk, Enhance Safety, and Expedite Development and Launch of Combination Products with Jama Connect®
In this datasheet, you'll learn how to manage risk, enhance safety, and expedite the development and launch of combination products with Jama Connect®.
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50:49WatchEffective Strategies and Solutions for Successful SaMD Project Execution
Join this webinar and discover and learn how to navigate the complex terrain of Medical Device Software Development.
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Jama Connect® Medical Device Risk Management Package Datasheet
Jama Connect® Medical Device Risk Management Package helps customers manage advanced risk activities to support their desired risk management strategy.
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5:58WatchJama Connect® Features in Five: SaMD Framework
In this Features in Five video, Romer De Los Santos - Senior Consultant at Jama Software® - will go over some highlights of the SaMD Framework in Jama Connect®
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47:26WatchApplication of Systems Engineering in Healthcare
In this webinar, Jama Software and Chris Unger of PracticalSE LLC have partnered up for an engaging webinar on the application of systems engineering in healthcare.
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Why Choose Jama Connect® Over Siemens Polarion for Requirements Management
Why choose Jama Connect® over Polarion for requirements managementt? Jama Connect is the ONLY solution that enables Live Traceability™ across best-of-breed tools for ocmplete end-to-end traceability.
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Learn How Jama Accelerates Medical Device Development While Reducing Risk
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Revolutionary Surgical Robotics Company, Monogram Orthopedics, Selects Jama Connect® For Its Unique Cloud Based Services and Ease of Use
In this customer story, we discuss why Monogram Orthopedics switched from Polarion® ALM to Jama Connect for faster time-to-market and an overall streamlined product development process.
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