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Complying with FDA Design Control Requirements Using Requirements Management Principles Mercedes Massana: So agenda for today is we’re going to talk a little bit about the design controls and what they are. We’re going to talk about requirements management and what that is. And then we’re going to talk about how the two relate to […]
Congratulations! Your organization has gained regulatory approval and launched its medical device product. The ‘History’ in Design History File may elicit impressions that all those design and development requirements are now done and considered part of the past. However, several components of the DHF continue as a reference and evolve, including requirements and risk management. […]
In the competitive world of medical device development, medical device companies can’t afford to lag behind the pack. Streamlining the design and approval process is vital to getting products to market in a timely manner. Proper documentation is key to a smooth approval process. One essential ingredient to medical device documentation is the Design History […]
magniX chooses Jama Connect for its ease of use, quick deployment, and to help modernize their requirements management program and demonstrate compliance with standards. Headquartered in Everett, Washington – located just outside of Seattle – magniX is the leading developer of propulsion systems for electric aircraft, including motors, inverters, and motor controllers. magniX is working to […]
As a medical device product development consultant, I often see start-up companies having trouble deciding what to prioritize – design controls and risk management or the quality management system (QMS). And what they mean specifically is, which software systems should the company invest in first – the requirements and risk management solution that will aid […]
Jama Software is being recognized for giving back to their community with a 2021 Tech Cares Award from TrustRadius. Today we are proud to announce that TrustRadius has recognized Jama Software with a 2021 Tech Cares Award. This second annual award celebrates companies that have gone above and beyond to provide strong Corporate Social Responsibility (CSR). “Living our mission […]
In this post, we look at non-functional requirements are tracked by agile product teams and how they impact the product development cycle. Imagine that you’re in the market for a new car. As you shop, you have a couple of non-negotiable features or attributes in mind, such as saving destinations within the car’s built-in GPS […]
In this blog post, experts from Cadence, OpsHub, and Jama Software talk about enabling digital transformation in the hardware and semiconductor industries. The relentless pace of innovation, rapidly changing markets, and increasing product complexity are creating intense pressures on companies in the semiconductor and hardware space. Some of the biggest challenges relate to scaling effectively […]