Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1
|
In part one of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect. Click HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®
Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in under five minutes.
In part one of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect.
We will share part two of this video series here once it’s published.
VIDEO TRANSCRIPT:
Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device & Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.
So the first thing I want to show is the general organization and layout of our new Medical Device & Life Sciences Solution 2.0. The first thing I want to show is that this new folder that actually has our new Medical Device framework and our other additional popular frameworks such as SaMD and Consumables frameworks. The other folder to mention is really kind of our new use case library that highlights additional use cases that we’ve seen across our three hundred-plus customers and their practices using Jama Connect.
So now let’s go ahead and jump into the tool. We’ve updated the relationship rule diagram with some minor improvements. The first thing we’ve done is really streamline the risk stream where we remove the validation trace and trace this now to an external resource item type. The purpose of this item type is a general documentation catch call for a lot of various traces that you may have.
RELATED: Jama Connect® Customer Success Programs
Balgos: The most common example is associated with risk. Not all risk controls are requirements, so we still need a way to trace to these non-requirement risk controls. These controls may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.
Another thing that we’ve done is actually updated our hazards library to include general hazards identified in ISO 14971. So you have pretty much a starting place with your hazard library The next item that I like to talk about is the risk Lookup Matrix. Available in [Jama Connect] 8.74, this feature allows a new Lookup Matrix risk analysis approach that automatically outputs the desired content based on the preconfigured Lookup table. This really aligns with [ISO] 14971.
Let me show you a quick demo of this. We’ve now implemented this as part of our Medical Device & Life Sciences Solution 2.0. As you can see here on the screen, I have a new item type called Risk Evaluation 2.0 that kind of again follows the general [ISO] 14971 schema of hazard sequence events, hazard situations, harms, but here is now where we’ve implemented this new Lookup Matrix feature. Where now I’ve identified the input pick list where I may be able to change this, and then that automatically updates my risk level based off that matrix.
RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®
Balgos: So for example here, if I went ahead and increased this to frequency and I increase my severity from here and this one as well. I can see that both my p total and risk analysis has been updated per the Lookup Matrix. We have an additional Features in Five video that shows cases a little bit more. So we definitely encourage you to look at that further.
The other thing that we wanted to share with particularly this Medical Device update is we have now included preconfigured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, when I look at my item type, I’ve now included preconfigured D FMEAs, Process FMEAs and, Use FMEAs that you may configure based on your organization.
RELATED: G2 Again Names Jama Connect® the Standout Leader in Requirements Management Software in their Summer 2023 Grid® Report
Balgos: The intent of this is really to continually improve and provide new solutions to our customers based on customer feedback, industry trends, and best practices.
The industry vertical solution updates expand new use cases and solutions to address complex challenges while continuing to comply with industry regulations. Please contact your Jama Connect success manager or consultant to learn how to implement these new solutions at your organization.
Thank you.
To view more Jama Connect Features in Five topics, visit: Jama Connect Features in Five Video Series
Medical Solution, Manager at Jama Software
Vincent Balgos currently leads the Medical Solution at Jama Software. Prior to joining Jama Software, he worked in the medical device / IVD industry for over 17 years with roles in systems engineering, product development and project management. Vincent has successful history in launching new products to the global regulated market, and is experienced in product development, risk management, quality systems, and medical device regulations.
Latest posts by Vincent Balgos (see all)
- Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges - December 17, 2024
- [Webinar Recap] Key Systems Engineering Skills: Critical Thinking and Problem Framing - November 21, 2024
- Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2 - July 28, 2023