Medical Device

Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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

See how Jama Connect’s modern requirements management solution helps the innovative team at Apex.AI deliver safety-critical applications in automotive 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.

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

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 customer story, we look at why Convergent Dental chose Jama Connect to manage compliance through in-depth reviews and to save valuable engineering time

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.

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.