Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.
The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
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.
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.
The hot issues are related to compliance, EU MDR and recalls.
Technology will continue to evolve to allow patients greater control over their healthcare.
With May 26, 2020 quickly approaching, every day counts.
Whatever the demands of international regulators, it is public expectations that will ultimately dictate the need for life sciences companies to prepare complete and accurate product data that patients and healthcare providers can scrutinize on demand.