In this blog, we’ll recap our whitepaper, “Understanding Integrated Risk Management for Medical Devices” – To read the entire paper, click HERE. Understanding Integrated Risk Management for Medical Devices Knowledge on best practices, how to integrate risk-based thinking into product development cycles, and the importance of having end-to-end traceability to improve risk management, shared by […]
Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA Intro Over the years, the burden of Computer Systems Validation (CSV) has resulted in medical device manufacturers avoiding implementation of automated manufacturing production systems or upgrading long-outdated versions of software. As part of the FDA’s ‘Case for Quality’ initiative […]
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from HealthITSecurity – MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks – which was originally […]
In this blog, we recap the “Understanding Integrated Risk Management for Medical Device” webinar. Companies involved in developing medical devices understand the importance of risk management, but their approaches can vary significantly in terms of the time it takes to manage risk, the ability to connect risks to specific requirements and tests, and the capacity […]
In this blog, we will recap a webinar on reducing risk in product development Over the last 20 years, product development complexity has expanded exponentially, creating innovations in areas such as space tourism, autonomous vehicles, satellite communications, and more. In this webinar, Kemi Lewis, Senior Consultant at Jama Software, will demonstrate how Jama Connect© creates Live […]
Medical Device Risk Management Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a […]
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 […]
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 […]
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