In this whitepaper, we cover the goals, practices, and artifacts of each Capability Maturity Model Integration (CMMI) level and discuss how Live Traceability™ can help you progress up the 5 levels.
5:17In 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
5:17In this video, learn how Jama Connect is commonly used in the context of a medical device Quality Management System (QMS)
46:50In this webinar, learn about observations and future considerations for medical device manufacturers in the EU market.
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.
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.
In this eBook, subject matter experts weigh in on medical device product development trends they’re anticipating in 2023 and beyond.
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.
7:59In 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.
In this guide, we take a comprehensive look at ISO/IEC/IEEE 15288:2015 goals, standards, and tools that help achieve compliance.
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.
Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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.
Download this datasheet to learn how Jama Connect for Medical Device Development accelerates innovation in medical device development while adhering to industry regulations.
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.
54:38Join our webinar to learn more about how a good requirements management process helps facilitate compliance with FDA design control requirements.
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)
49:26Attendees 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.
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.
Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA, and 21 CFR Part 820.
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.
