Pre-submission meetings are a good opportunity to interact with regulators, educate them on your technology and gather valuable feedback for your submission.However, if not...

The new US FDA draft cybersecurity guidance requires you to test cybersecurity, but when should you conduct software security testing? The 2022 draft cybersecurity guidance...

titlestatusdateYY 9706.268-2022 Medical Electrical Equipment Part 2-68: Particular Requirements for Basic Safety and Basic Performance of X-ray Image-guided Radiotherapy Equipment for Electron Accelerators, Light...

Posted by Rob Packard on January 10, 2023 The FDA patches the regulations with guidance documents, but there is a desperate need...

This is an opinion editorial by Max Keidun, the CEO of peer-to-peer bitcoin exchange Hodl Hodl.The bitcoin lending space has suffered from several major...

Posted by Rob Packard on January 4, 2023 What are the best human factors questions to ask the FDA during a pre-submission...

Don’t miss this opportunity to learn more about how IoT is connecting the world by giving individuals the ability to create their own...

A 2013 study by the US Department of Transportation (US DoT) is receiving newfound attention, due to the recent release of...

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Podcast: Play in new window | Download (Duration: 1:06:17 — 30.3MB) We speak with the owner of a company that designs and creates airline safety...

Posted by Rob Packard on November 8, 2022 This article provides an overview of the new 510k electronic submission guidance document that...

Climate change is no longer a distant threat but is already making us face perilous “tipping points” that could alter our...