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1Blog Post

Celebrating the 2022 Medical Design Excellence Awards Winners & Finalists

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 Medical Device and Diagnostic Industry – Celebrating the 2022 Medical Design Excellence Awards Winners & Finalists  […]

2Blog Post

Requirement Debt™: A Medical Product Program Risk

In this blog, we discuss key takeaways from a recent whitepaper, written by Ivan Ma, discussing Requirement Debt™. What is Requirement Debt™ Requirement Debt is defined as the gap between product requirements + requirement traceability and the perceived maturity of the program + product. How Reducing Requirement Debt Reduces Project Risk It is imperative that […]

3Blog Post

2022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability

In many ways 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will […]

4Blog Post

Software as a Medical Device (SaMD): Four Key Development Best Practices

This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants.  SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or […]

5Blog Post

Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)

Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science spaces are no exceptions. ML can help medical systems improve the identification and diagnosis of disease, create personalized medicine, and help with drug discovery and […]