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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. […]
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 […]
One of the early steps I advise my clients to take when developing their medical device is to determine the class and classifications of their medical device. In conjunction with the complexity of the device, understanding the class and classification sets the foundation for your product development timeline and effort. This post gives a basic […]
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
This is Part 2 of a series examining the role legacy requirements management solutions, such as IBM® DOORS®, play in introducing project risk to the product development process. To read Part 1, visit Why Migrate, Why Now?: Part 1 5 Common Migration Myths Debunked Transitioning to a new solution doesn’t have to be challenging; however, […]
In this post, we look at how Teledyne e2v leverages Jama Connect for improved communication and better risk management. Teledyne e2v is a global leader in specialized components and subsystems for innovative solutions in medical, science, aerospace, defense, and industrial applications. Over 1600 employees in countries across Europe, America, and Asia. As a result of their […]
Trace Score™ – An Empirical Way to Reduce the Risk of Late Requirements Executive Summary One of the main causes of rework, delays, and cost overruns in product development is the creation of new requirements late in the process. This is a well-known risk in product development, but what management practices can empirically be shown […]
Introducing Jama Connect for Airborne Systems, built to facilitate digital engineering and accelerates time-to-market in the development of aircraft systems
Jama Connect® Features in Five: Nuclear Reactor Design and I&C Development Solution Learn how you can supercharge your systems development process! We always want to be respectful of your valuable time. Still, in this Features in Five video, we do go beyond the promised five-minute format to include an information-packed session, hosted by Vlad Tanasescu, […]
Jama Connect® Features in Five: Empowering Project Owners in the AEC Industry Managing construction projects can feel like trying to juggle a dozen tasks at once while standing on a tightrope. For project owners in the architecture, engineering, and construction (AEC) industry, the stakes are even higher. Misalignment among stakeholders, inflated risk costs, and compliance […]