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[…] that we provide are aligned to the three standards, the Automotive Spice, ISO 26262 and ISO 21434. Only certain areas of those standards are in scope. For example, things like part seven of the ISO 26262 for production and operation and decommissioning are not covered here. But you will see some of these sections […]
[…] for many applications, leaving companies of all sizes–with tasks that need to be completed and no workers or automation available to take the work on. Take for example Wisconsin-based Processed Metal Innovators (PMI), a metal fabricator that produces hundreds of different stamped and welded metal parts. Erik Larson, vice president of operations at PMI, […]
[…] frequently occurring failure or new failure mode indicates an investigation is warranted and re-evaluation of the risk. Depending on the outcome, corrective action may be needed. For example, during design and development, it was determined that a sensor failure leading to customer annoyance occurred rarely, leading to a low risk rating at the time […]
[…] a timely manner; 2) Understanding what topics the investigator may request go to next and prepare accordingly; and 3) Keeping a record of what the investigator has examined. To that end, here are roles to have during an inspection. Host – Serves as the primary interface with the investigator. This role is typically best […]
In this post, we highlight and summarize parts of the new “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.” It is important to note that this content contains non-binding guidance and therefore is not currently for implementation. With that said, while […]
[…] through the entire product development process and lifecycle. Many see risk management as discrete deliverables completed by different team members at certain phases of product development. For example, a risk analysis that focuses on the intended use and reasonably foreseeable misuse is typically first drafted at the onset of design controls by primarily those […]
[…] to learn about what the standard is and why it’s important to automotive development. In this post, we take a look at ISO 26262 vs. ASPICE and examine the similarities and differences between these two important automotive standards. ISO 26262 vs. ASPICE for Automotive Compliance Of course, automotive companies already use ISO 26262, and […]
[…] apply appropriate rigor for final reviews. In addition, integrating item workflow with approval reviews can eliminate manual processes and reduce human error. In this blog post, we examine a generic approach to reviews and review coverage, independent of the application used. In the second half of this post, we’ll look into the way Jama […]
[…] by Dahwood Ahmed and published on April 10, 2024. How Manufacturing Will Reap the Rewards of Smart Factories Dahwood Ahmed, Regional Director of UK&I at Extreme Networks, examines the concept of Industry 4.0 and how smart factories will push manufacturing into this. Manufacturing is entering Industry 4.0, giving rise to the world’s first smart […]
[…] stage in the creation of medical devices. It entails evaluating the device’s possible benefits as well as drawbacks and deciding if the advantages outweigh the disadvantages. This examination aids in ensuring that medical devices are reliable, safe, and capable of being used by patients without harm. The global standard for risk management of medical […]