Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or invasive tools used only transiently in body orifices, such as dental impression materials. Class I devices can be active, such as examination lamps. However, the MDCG 2021–24 Guidance on…
One of the vital aspects in drug development is the clinical evaluation of products to be marketed. It helps ascertain that a drug is free from any danger or risk as well as effective and proper for usage before being sold in the market. This compulsory process, which goes through rules and regulations, aims to…
In medical devices, marketing compliance with the regulatory requirements may not be a mere formality but a policy to observe in order to provide safe and quality products. Clinical Evaluation Services are very important when it comes to meeting these kinds of standards. But, getting in and out of clinical trials, documentation, and reporting prove…