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An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices In the world of modern medicine and healthcare, software plays an integral role in the functionality, monitoring, and management of medical devices. These software components can range from simple interfaces to complex algorithms that drive critical medical decisions. Ensuring the safety and effectiveness […]
What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security A comprehensive guide to understanding ANSI/AAMI SW96:2023 and mitigating security risks Introduction Managing risk around a medical device’s entire lifecycle has become increasingly complex. Many devices use third-party components, which is especially true for devices that require a network to operate. This increased need […]
2024 Predictions for Medical Device & Life Sciences Product, Systems, and Software Development As the medical device & life sciences industry transitions into 2024, we aim to gain a deeper insight into the factors driving transformation in the development of products, systems, and software and explore how teams within this sector are adapting to meet […]
Empower your teams with insights and solutions that transcend the challenges of medical device software development. Navigate the complex terrain of medical device software development and learn crucial insights and practical solutions to propel your projects forward. In this webinar, Romer De Los Santos, Senior Consultant at Jama Software®, guides you through: The new SaMD […]
Leveraging Jama Connect® for Effective Development of Combination Products Developing combination devices, also called combination products, such as inhalers or injectables, is a complex and interdisciplinary endeavor that lies at the intersection of pharmaceuticals, biologics, engineering, and medical science. These innovative devices are designed to provide patients with a more convenient and effective way to […]
When it comes to healthcare, the first to market usually gains 80% of the market share, making development speed one of the most crucial aspects of success – or failure. That’s why many organizations are looking at systems engineering as a way of connecting needs to solutions. In this webinar, Chris Unger of PracticalSE LLC […]
Jama Connect® Features in Five: SaMD Framework Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes. In this Features in Five video, Romer De Los Santos – […]
UK regulators name 3 approved bodies to ease device certification bottleneck A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.” Dive Brief: The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three more bodies to certify medical devices in the U.K. As a result of Brexit, […]
EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights Are you grappling with the intricacies of the EU Medical Device Regulation (EU MDR) and searching for clear answers to your most pressing questions? Look no further! In this blog post, we’ve teamed up with subject matter expert Saby Ágai, Senior Professional Services Consultant at […]
Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction. Seven-year-old surgical robotics company Monogram Orthopedics, which went public in May, is aiming to take on medtech heavyweights such as Stryker and […]