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Tag: malfunctions

NMPA Review Report Released for Head and Neck X-ray Stereotactic Radiosurgery System

The NMPA granted innovation approvals to Zap Surgical’s head and neck X-ray stereotactic radiosurgery system and issued a review report. It is the seventh imported...

HSA Draft Guidance on Clinical Evaluation: Definitions | RegDesk

The new article addresses the aspects related to the key concepts used in the context of clinical evaluation. Table of content ...

Tesla launched its own car insurance. These drivers say it’s a lemon: ‘totally ridiculous’ – Autoblog

In February, Mark Bova purchased a used 2018 Tesla Model S. Before leaving the dealer, he bought insurance from Tesla itself, finding the initial $93 monthly premium “really reasonable.”...

FDA Guidance on Selecting Predicates for 510(k): Devices Cleared Based on Established Methods / Devices That Meet Expectations – RegDesk

The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that...

FDA Guidance on Selecting Predicates for 510(k): Devices Cleared Based on Established Methods / Devices That Meet Expectations | RegDesk

The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods,...

How To Fix The Dead By Daylight Error Code 8012

If you’re a DbD player, you likely encountered connection errors in the game before. Hence, here is how to fix the Dead...

ELDIS Pardubice: Shaping the skies with next-gen radar – ACE (Aerospace Central Europe)

Where radiomagnetic technology meets the future ELDIS’s evolution from a legacy of radiomagnetic technology to its present-day position as an innovator in radar technology showcases...

Automotive-grade MIPI PHY IP drives multi-sensor solutions – Semiwiki

Sensors are critical to every new automotive design, whether created for a driver or self-driving. Frame rates and resolution for car, truck, and SUV...

Using The FDA’s Best Practices for Selecting a Predicate Device

One of the more common pathways to commercialize a medical device into the United States is through the 510(k) marketing submission, also known as...

BfArM Guidance on Fast-Track Process for Digital Health Applications: Quality Requirements – RegDesk

The article describes in detail the further quality requirements imposed with respect to digital health applications intended to...

How an Energy Management System Enhances Energy and Environmental Efficiency for Utility Companies

Title: How an Energy Management System Enhances Energy and Environmental Efficiency for Utility CompaniesIntroduction:In today's world, where sustainability and environmental consciousness are gaining increasing...

Fuel for Thought: Waiting for Autonomy

LISTEN TO A PODCAST ON THIS TOPIC WITH S&P GLOBAL MOBILITY EXPERTSFive years ago, hype surrounding "autopilot" cars peaked. But S&P Global Mobility's updated forecast offers...

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