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The outcomes of a clinical examination of your medical device are documented in a Clinical Evaluation Report (CER). A CER is made up of clinical data that has been thoroughly examined and was obtained from either a clinical investigation of your device or the findings of studies on devices that are significantly similar to it. […]
Medical devices developed for human use are used for either diagnosis or treatment. They could be a device, an appliance, or a substance. Additionally, these services have been developed for both routine patient care and medical research. Making a new medical technology safe for human use is a challenging undertaking for researchers in charge of […]
The MDR is a comprehensive revamp of medical device regulation in Europe with the goal of enhancing quality and safety. Regulation (EU) 2017/746’s guidelines for in vitro diagnostic medical devices (IVD) have recently been expanded. Consequently, the regulation now covers a wider range of device kinds than it did in the past. The MDCG-set-up ad […]
The COVID-19 pandemic has compelled the medical device and IVD industry to think of innovative, creative ways to satisfy regulatory requirements without compromising patient safety. The pandemic has managed to spur some beneficial developments despite its devastation. For instance, to conduct remote audits, auditing associations are increasingly using immersive technologies. The application of the new […]
By registering its trademark, LLP prevents third parties from misusing its goods and services. A trademark registration provides the owner the exclusive right to use the company’s goods or services. It makes the brand easier for consumers to recognize, distinguish from competitors, and identify. As was already mentioned, a trademark stands for a genuine product or […]