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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 […]
Understanding IATF 16949: A Quick Guide to Automotive Quality Management In the ever-evolving landscape of the automotive industry, ensuring product quality and safety is paramount. One key standard that plays a crucial role in this pursuit is IATF 16949. In this article, we will delve into the intricacies of IATF 16949, exploring its significance, key […]
Decoding The FDA’s Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma The current state of validation is seen as a hindrance to quicker deployments, with an emphasis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 […]
Streamlining SOC2 Type 2 Compliance: How Jama Connect® Can Help Enable Audit Success In today’s business landscape, technology and data play a crucial role. Therefore, it is of utmost importance to prioritize the security and privacy of sensitive information. One way to do this is by undergoing a SOC2 Type 2 audit. A SOC2 audit […]
The Seven Steps to Performing FMEA Welcome to this deep dive into the world of FMEA Failure Mode and Effects Analysis (FMEA) is a powerful tool used in various industries to identify and mitigate potential failures in a process, product, or system. In this blog, we will take a detailed look at the seven steps […]
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 […]
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 […]
Evaluate Your Compliance Against ASPICE, ISO 26262, or ISO 21434 with Diagnostic Services Offerings from Jama Software® During the webinar, experts Steve Rush, Principal Consultant, and Sampath Yerramalla, Senior Consultant, explored various service offerings within Jama Connect that provide insights into compliance status against these critical automotive standards. Key takeaways from this webinar: Learn about available […]
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, […]