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FDA Outlines its Approach to Artificial Intelligence Regulation “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development. U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work […]
Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification Since the introduction of the EU MDR in 2017, the medical device industry has learned just how challenging obtaining initial MDR certification truly is. According to a survey of notified bodies, the number of certificates issued as of June 2023 covers roughly one-third of the […]
Applications of Systems Engineering in Healthcare When it comes to healthcare, time to market is one of the most crucial aspects of success or failure. However, medical product development teams face several challenges that slow product development, and in the quest to speed up the process, some teams are turning to systems engineering to improve […]
Decoding The FDA’s Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma The current state of validation is seen as a hindrance to quicker deployments, with an emphasis on adhering to thorough documentation practices instead of building systems that align effectively with their intended use. A risk-based approach to validation has been around […]
Key Systems Engineering Skills: Critical Thinking and Problem Framing Elevate your team’s success by exploring the role of critical thinking in a system engineering competency model. In this insightful session, Chris Unger, Retired GE Healthcare Chief Systems Engineering Officer and Principal at PracticalSE LLC, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®, […]
Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US regulation on quality […]
Secure by Design: A Crucial Imperative for Medical Device Teams In today’s healthcare landscape, technology plays a crucial role in patient care. Medical devices have become essential for monitoring vital signs and administering treatments. However, as these devices become more connected and complex, ensuring their security is now more important than ever. This is where […]
Pioneering Excellence in Healthcare: Q&A with Systems Engineering in Healthcare On December 5th, 2023, Jama Software® hosted an exclusive one-day thought leadership event, featuring industry experts Chris Unger – Retired GE Healthcare Chief Systems Engineering Officer – PracticalSE LLC, Bijan Elahi – Founder of MedTech Safety, and Vincent Balgos – Director of Medical Device Solutions […]
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 […]