Part One: Jama Connect™ for Medical Device Development Explained

May 28, 2020 Zeb Geary

Today, Jama Software announces a new solution: Jama Connect for Medical Device Development. The launch feels especially relevant right now. Over the next few weeks I’ll share details about it with you here in the blog. I’m going to talk about:

  • The solution background: why it came to be and what it does.
  • Solution Components
  • Design Inputs
  • Connect Design Inputs, Design Outputs and Verification
  • Traceability

We’re pleased we’ll be able to help medical device manufacturers support design control activities in the highly regulated product delivery environment and contribute to their goals of quality and safety.

Streamlined and focused configuration for medical device development.

The idea for the Jama Connect for Medical Device Development solution grew from the need to align quickly to medical device regulations and standards within a requirements platform.

The highly configurable Jama Connect platform allows customers to align the system with specific requirements, risk, and test process needs. If there’s a particular type of information to capture or a specific list of values that would support the overarching process, customers can configure Jama Connect to align and support it.

However, a highly configurable system introduces challenges. During deployments, you have to ask, “Yes, we can do anything, but what should we do?” Think of a highly configurable system as a blank canvas. You can find yourself staring, directionless, and not know where to begin.

That matters when there’s an entire team staring at the blank canvas. It wastes resources and impacts the time it takes to gain value from the system. In the end, the result can be a misaligned, frustrating deployment and low user adoption.

An out-of-box configuration that brings immediate benefits.

The challenge described above is precisely why Jama Software created the Jama Connect for Medical Device Development solution. We wanted to help Medical Device manufacturers who deploy Jama Connect in a highly regulated environment:

  • Increase the value of Jama Connect, and decrease the time to realize that value.
  • Access a recommended, out-of-the-box configuration.
  • Maintain alignment with design control regulations and standards that Jama Connect is best suited to address.

With the Jama Connect for Medical Device Development solution, deployments no longer start with a blank canvas. Instead, the picture comes out of the box, justified and properly aligned with medical device regulations and standards. Configuration is still possible and valuable, but streamlined and focused.

Customers can hold an out-of-the-box configuration and recommended guidance against their operating procedures to:

  • Identify and justify unique, customer-specific needs.  
  • Determine the best approach to address those needs.  
  • Incorporate customer-specific nuances for tighter alignment to the company operating procedures.  

In next week’s blog post, we’ll explore solution components in more detail.

Discover more details and watch a demo of the new Jama Connect for Medical Device Development solution here.





About the Author

Senior Consultant in Professional Services

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