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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 […]
Cybersecurity Concerns for Manufacturers in 2024 The more networked and data-centric manufacturing becomes, the more manufacturing leaders ought not consider cybersecurity as something that only concerns the IT department. New SEC reporting rules and high-profile hacks against manufacturers with multimillion-dollar price tags last year curtly demonstrate the point. Org-wide planning provides the best defense against […]
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Decoding The FDA’s Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma The current state of validation is seen as a hindrance to quicker deployments, with an emphasis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 […]
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 […]
AI, XR and Data: Manufacturing Technology Predictions for 2024 If we’re finished with the hype cycle, we’re probably talking about a technology that’s here to stay. So, when IndustryWeek asks manufacturers and analysts for their predictions about manufacturing technology in the coming year, we’re looking for the most mature technologies with the widest adoption rates. […]
Expanding EV Infrastructure in the US: Both On- and Off-Road The expansion of electric vehicle infrastructure in the US has been challenged by various issues, from governance to location. Here, we explore the issues and how they can be combated. The evolution and expansion of electric vehicle (EV) infrastructure, encompassing both on-road charging stations and […]