FMEA Framework for Medical Device Development

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.

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.

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.

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.

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).

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.

In this customer story, we examine how Jama Software helps Infineon manage complex product development subject to regulatory compliance and increase efficiency.

Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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

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.

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).

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.

Download this datasheet to learn how Jama Connect for Medical Device Development accelerates innovation in medical device development while adhering to industry regulations.

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.

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.

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