Medical Device

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

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.

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.

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.

Best practices for medical device design reviews, including the six necessary attributes when establishing a framework for planning and implementing a successful design review process.

In this paper, we examine how and why the Easy Approach to Requirements Engineering Syntax (EARS) notation enables cross-team collaboration, improves product requirements, and reduces project risk.

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.

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.

The Jama Connect Validation Kit for Medical Device and Drug Development teams is designed to reduce the time required for validation, define safety-critical workflows, and streamline your process.

Learn how Jama Connect for Companion MBSE provides a path for MBSE adoption where the application of collaboration, modeling, and methods reduces time and effort across the lifecycle.

TOMTEC used Jama Connect to improve the product development process, and Jama Software Professional Services for hands-on help with the platform.

In this infographic, you’ll learn how Jama Connect can help accelerate innovation, maintain product quality, and manage ever-changing complex regulations in medical device development.

Learn more about how the Finnish Red Cross Blood Service leverages Jama Connect to modernize their processes, improve communication, and shorten review cycles.

Download this datasheet to learn how to analyze and mitigate potential failure modes or risks for medical device development to ensure quality and accelerate time to market.