[Webinar Recap] From Requirements to Regulatory: How AI Is Transforming Submission Readiness
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This blog recaps a preview of this webinar, watch the entire thing here “From Requirements to Regulatory: How AI Is Transforming Submission Readiness”
Stop Scrambling for Submissions. Build Readiness Into Your Process With AI.
Regulatory submissions often become a stressful, last-minute rush, increasing risk, rework, and frustration. But what if you could embed submission readiness into your process from the start? Artificial Intelligence (AI) is making this a reality by connecting requirements, regulatory guidance, and ongoing monitoring seamlessly throughout the product lifecycle.
In this webinar, Adam Smith, CEO of Agent Astro, and Tom Rish, Senior Business Development Manager at Jama Software, share practical insights into how AI helps teams stay submission-ready, reduce delays, and maintain compliance without slowing development.
Key Takeaways:
- The benefits of integrating submission readiness early to save time and reduce stress.
- How AI can track requirements and ensure traceability between design decisions and regulatory guidelines.
- Tips for maintaining compliance as new regulations emerge and post-market data is collected.
- A look at how AI will continue to shape regulatory processes in the future.
WEBINAR PREVIEW BELOW – WATCH ENTIRE WEBINAR HERE
TRANSCRIPT PREVIEW
From Requirements to Regulatory: How AI Is Transforming Submission Readiness
Tom Rish: Thank you to everyone for being here today. We have a very exciting webinar about AI, a hot topic, of course, as always, and so I’m excited to dive into it. Before we do, I just want to talk very briefly about Jama Software and what we do. I know some of you have watched previous webinars, and you know all about this, but I want to give a high-level overview and talk just a little bit about how we are looking to incorporate AI to make your life easier when it comes to requirements management. So first, Jama Connect ®. As you all know, when it comes to launching a product, you have to keep track of all your requirements, all of your risk items, all of your testing, and everything like that. It can be a lot of work, especially on spreadsheets or disjointed systems, whatever it is you use.
And at Jama Software, what we’re trying to do is make it simple for you. We want you to focus on designing. We want you to focus on testing. We want you to focus on important things like the safety of the patient and not worry as much about paperwork and organizing everything. A lot of times, as you know, that’s done at the end, and it’s a checkbox activity. But we have a system, as you can see there on the left. I know many of you are used to a lot of documentation and everything. We want to bring that into a very organized V model that you’ve all seen there. Start with user needs. Enter those right into the system, build as you go. We can connect all of the systems you use, whether it’s software products, and you’re using a lot of things like Jira, GitHub, things like that, all your test systems, but we want to keep things organized.
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Rish: What’s cool about Jama Connect is that we work with all industries, but we have frameworks specifically for medical devices. So out of the box, we’re able to build a framework where you can match it to your processes to track your user needs, design controls, risk management, and all of your tests. We have real-time collaboration so that you can do all of your reviews and comments in the software, create libraries, and release things. And finally, we have the AI guidance that I’m here to talk about today.
A couple of things here on this slide. This is mostly focused on requirements management. One of them is there today and available for use. Some of our customers are using it, and we’ve gotten some good feedback. Some of these here are things that are coming in the future. First thing that we have here today, though, is a scoring system. So when you enter your requirements into Jama Connect, we have AI that scans through INCOSE and EARS guidance and tells you how well this requirement is written. So it gives you a scoring system to tell you, “Hey, this one looks pretty good,” or, “This one doesn’t, and here’s why this is the rule or the guidance that it doesn’t quite meet.” So that’s ready to use today. I’ve talked to a few customers already who have said how helpful it has been for downstream operations like testing to create better testing and things like that.
We’re also working on some things where we will help rewrite requirements if needed. So not only does it give you scores, but help you rewrite them so that they can match the guidances better. So if you give it an initial draft of a requirement, we’ll go through, we’ll score it, but we’ll also give you some recommendations for changing it.
I think ideally everyone’s probably wondering how you just create them for us. So we are looking into some ways that we can enter some project inputs into the software, and then it will give you some requirements for you. So that will be in the future, along with PDF parsing. A lot of you come with existing documentation already. You might have requirements documents, software specification documents, things like that. We’re working on some AI features that will take those and create requirements automatically for you in the structure that they are.
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Rish: A couple of other things. One thing that is new now, again, is test case generation. When you have your requirements in there, what we want to do is help you create good testing and guidance for creating the right acceptance criteria and things like that for your testing. Also, looking at an AI assistant, I think everyone is used to AI assistance these days, but a more conversational workflow where you can enter information into the software, and we’ll give you some guidance and feedback on that. Also, looking into ways that we can take your requirements and give you tips on how to link them together better, create better relationships, and finally help with reviews to detect areas that maybe are high risk.
I think later on, what we’re going to talk about is how the FDA and other regulatory bodies are starting to incorporate AI. So what we want to do is help you get it right up front so that when it’s sent over there, you feel good about everything. So that’s a little bit about Jama and how we’re using AI today. Now for the main event, I’m excited to pass it over to Adam. I met Adam at the MedTech conference in San Diego. And when I went up to his booth, I was instantly impressed. I think as a product development engineer, I spent a lot of time searching through the FDA databases.
And there are a lot of them, as I’m sure you all know, and there is excellent information in those databases. The challenging part is that it’s hard to go to each one every time and find what you need. The interfaces are a little outdated at times as well. You can find everything, but it’s just not easy. And what I always thought is, why can’t anybody scrape this information or pull this information and use it in a better format and make our lives easier? And that’s exactly what Adam and his team are doing. And so I’m excited to hand it over to him, and he will tell you more about Agent Astro and give some practical tips about how to better use AI throughout your process.
TO WATCH THIS ENTIRE WEBINAR, VISIT:
From Requirements to Regulatory: How AI Is Transforming Submission Readiness
Senior Product Marketing Manager at Jama Software
Tom Rish is a biomedical engineer with over 15 years of experience developing medical devices. His work has spanned the entire MedTech product lifecycle, from initial concept through market launch. He is passionate about helping others navigate the complex journey of bringing a device to market so that patients around the world can benefit from life-changing technologies. Tom is currently a member of the Product Marketing team at Jama Software.
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- Expert Perspectives: A Method to Assess Benefit-Risk More Objectively for Healthcare Applications - January 29, 2026