Medical Device

2022 Industry Predictions for Medical Device Development

In this eBook, industry experts discuss challenges, disruptors, and tips for standing above the competition in medical device/life science products, systems, and software development.

The Complete Guide to ISO 13485 for Medical Devices

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.

Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

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

Jama Connect for Medical Device Development

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.

Your Guide for Selecting a Medical Device Development Platform

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.

How to Execute a Successful Design Review When Building Medical Devices

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.

FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?

Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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

2021 Medical Device Industry Trends and Predictions

For this information-packed eBook, Jama Software teamed up with Beanstock Ventures to weigh in on trends and predictions for medical device development in the new year and beyond.

Requirements Debt: A Medical Product Program Risk

Read this whitepaper to learn more about the impact of poor requirement definition and traceability on time, scope, and budget – and how reducing requirement debt reduces project risk.

Adopting the EARS Notation to Improve Requirements Engineering

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.

The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

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.

Medical Device Startup, Proprio, Chooses Jama Connect® to Drive Innovation

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).

Celebrating the Innovative Teams We've Empowered

Get a brief overview of four Jama Software customer stories. Rimac car manufacturer, Jones Lang LaSalle Incorporated (JLL), Deloitte, and RBC Medical Innovations each faced unique challenges.

Streamlining Complex Systems Development for Faster Compliance

What the New Medical Device Regulations (EU MDR) Mean for You

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.

Validation Kit for Medical Device & Drug Development Teams

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.