Part One: Jama Connect™ for Medical Device Development Explained
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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.
Note: Now that our medical device blog series is concluded, you can go back and read the series intro, Part II, and Part III.
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.
Principal Consultant at Jama Software
Zeb Geary is a Principal Consultant with over 15 years of experience in requirements, test, project and resource management. He has a Masters degree in Psychology and is certified as a SAFe Agilist.
Zeb has been with Jama Software for over 5 years; working with ~100 of Jama's most complex customers in a variety of industries. Zeb is the primary author of Jama’s Medical Device solution offering and has extensive experience working with customers building safety critical products. He has a passion for organizational change management and helping his clients figure out how to successfully deploy and adopt software solutions.
In his day-to-day at Jama, Zeb partners with companies making complex products to determine how to best deploy and use Jama’s solutions within their product development process.
Before Jama, Zeb worked as a Business Analyst for Kaiser Permanente and as a Sr. Solutions Consultant at CA leading Clarity PPM implementations. Additionally Zeb has an extensive history involved in local social services oriented volunteer work.
Zeb has been with Jama Software for over 5 years; working with ~100 of Jama's most complex customers in a variety of industries. Zeb is the primary author of Jama’s Medical Device solution offering and has extensive experience working with customers building safety critical products. He has a passion for organizational change management and helping his clients figure out how to successfully deploy and adopt software solutions.
In his day-to-day at Jama, Zeb partners with companies making complex products to determine how to best deploy and use Jama’s solutions within their product development process.
Before Jama, Zeb worked as a Business Analyst for Kaiser Permanente and as a Sr. Solutions Consultant at CA leading Clarity PPM implementations. Additionally Zeb has an extensive history involved in local social services oriented volunteer work.
Latest posts by Zeb Geary (see all)
- Jama Connect® Features in Five: Reuse & Sync - November 3, 2023
- Part V: Using the Trace as a Way to Work - June 25, 2020
- Part IV: Connecting Design Controls, Including Design Inputs, Design Outputs and Verifications - June 18, 2020