The safety communication notes that patients being monitored via GE’s Healthcare Clinical Information Central Stations and Telemetry Services could be at risk.
Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
2020 should be a pivotal year in which the microcosm of medical devices moves out of the shadows and joins the mainstream healthcare conversation.
This two-part virtual workshop will guide participants through the process of how to write effective documents.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The goal is to establish a baseline of cybersecurity hygiene and assurance for devices that are part of the national critical infrastructure software supply chain.
How will you make your company more attractive to investors?
When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.