Medical Devices and IVD Regulatory Documentation
clinOXY with specialized resources in Medical Device Regulatory writing can offer various services to the Medical Device Manufacturers to get CE mark of your products. Our expert regulatory writers can produce 100% quality Regulatory work for our clients.
Clinical Evaluation Report(CER)
Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that is collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices.
Summary of Safety and Clinical Performance (SSCP)
The SSCP is intended to provide healthcare workers and relevant patients access to current clinical data and other information about the safety and clinical performance of the medical device.
Instructions for use(IFU)
The information provided by the manufacturer to inform the user of the device’s intended purpose, proper use and of any precautions to be taken.
WHAT WE DO?
clinOXY with specialized resources in Medical Device Regulatory writing can offer various services to the Medical Device Manufacturers to get CE mark of their products. Our experienced regulatory writers can produce 100% quality Regulatory work for our clients.
clinOXY provides a wide range of high-quality writing services for the Pharma- ceutical, Biotech, Healthcare, and Medical devices companies across the Globe. We are specialists in clinical regulatory documentation and clinical trials documentation. We proactively plan, coordinate, and write our clients clinical and scientific communications documentation to meet aggressive timelines, with a readability that reduces the time for review and approval.
+91 94 925 11123