The Complete Guide to ISO/IEC/IEEE 15288:2015 — Systems and Software Engineering and Lifecycle Processes

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.

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Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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

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.

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.

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.

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 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 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).