Jul 10, 2020
Are you a device manufacturer in the medical industry? Then you may be thinking that the FDA design controls are confusing terms on your process. These regulatory design requirements shouldn’t be shrouded in confusion, and we share some tips below that will help you enjoy being a biomedical product designer who meets or even surpasses the FDA regulatory requirements.
It Would Be Best If You Didn’t Believe in Misconceptions
A heavy load of documentation has been the biggest misconception about meeting the FDA design controls. If you have volumes of documentation on how to meet FDA design requirements, then your design controls are obsolete, and they need…
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A flaw in Docker Hub, the registry where container images are published and downloaded, let one user push, pull, or delete images as another user. Docker fixed the flaw on September 30 and says it found no evidence that anyone exploited it. The flaw was in the feature that converts a personal account into an organization, Docker said in a security advisory on October 12.
Read moreAn attacker chained three zero-day flaws in Ivanti Connect Secure, a VPN appliance, to run commands as root without logging in, security firm Volexity said on October 13. Ivanti has released fixes for two of the flaws and told customers on affected versions to "act immediately." A fix for the third is still pending, according to Volexity. Volexity, which reported the flaws to Ivanti,
Read moreA flaw in SAP's Cloud SDK for Python can send an application's OAuth2 client credentials to a server an attacker controls, SAP said in a security advisory on October 13. The flaw affects multi-tenant applications on SAP Business Technology Platform (BTP) that use the SDK, SAP's official Python client for BTP services. An attacker must be able to control the tenant subdomain,
Read moreApple unveiled the device as it continues its foray into artificial intelligence and tries to prove it can still innovate.
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Read moreGitHub has taken the step of expiring unvalidated npm trusted publishing configurations 48 hours after creation after researchers found that it was possible for an attacker to push new versions of a different user's package without having to steal their credentials. "Your configuration becomes validated and exempt from expiry after its first successful publish," the Microsoft-owned subsidiary
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Read moreApple unveiled its HomeView smart home hub, updated HomePod Mini 2, new Apple TV 4K and Apple Home Collection at its ‘Welcome Home’ event on October 13, 2026. The HomeView features a touchscreen, AI-powered Siri, personalised interfaces and smart home controls, with a starting price of $299.
Read moreThe Norwegian Data Protection Authority (DPA) has fined Xandr, an advertising unit owned by Microsoft, €8.6 million ($9.62 million) for illegally relaying Grindr users' sensitive data to advertisers. The administrative penalty is the largest issued by the data protection watchdog, arguing the case merited a high fine because of the "very serious" nature of the breach. The infringements
Read moreHuawei Technologies has shipped more than 100 million devices powered by its Kirin processors since 2023, when it returned to the smartphone market with a new generation of premium handsets. The company says testing of its next-generation Kirin 2027 chip is also progressing in line with expectations. The company disclosed the figure on Tuesday as it unveiled new details about its flagship Kirin 9050 series, the first mass-produced chip using its proprietary LogicFolding architecture, developed...
Read moreA wife and mother claims she had a life-changing meeting with Jesus in the afterlife while her husband attempted to kill her before he could be cut out of her life insurance policy.
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