This paper discusses some of the issues that arise during RE and describe how the Easy Approach to Requirements Syntax (EARS) notation helps achieve desired outcomes and overcome many common development challenges by enabling you to improve your requirements engineering practices.
Download this whitepaper to learn more about how the EARS notation:
Enables cross-team collaboration and synergy
Improves product requirements
Reduces overall project risk
Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device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.
In this medical device research study from Axendia, a leading Life-Sciences Analyst firm, see how ineffective requirements management can negatively impact budgets, traceability, and V&V activities.
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.
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.
49:26Attendees will hear directly from industry leaders Jama Software, MDM Engineering Consultants, & Beanstock Ventures about critical standards and best practices to follow in digital health development.
Tips for Medical Device Companies, Interested in Risk Techniques following ISO 14971, ISO 13485, FMEA, FTA, and 21 CFR Part 820.
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.
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.
37:25Join Jama Software and Axendia for our webinar reporting on our groundbreaking research highlighting the costly impact of ineffective requirements management in medical device development.
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.
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.
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).
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.
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.
Why choose Jama Software for your requirements management software? We're the industry leader helping innovative companies modernize, digitize, and transform the complex product development process.
