CEP/CER, PSUR, and PMCF are essential components of the regulatory compliance requirements for the medical device industry. These regulatory documents are essential for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. According to the new EU Medical Device Regulation, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are mandatory […]
It is very important for a medical device manufacturer to perform a thorough clinical evaluation and literature research so that they can document state of art, incorporate safety, increase efficiency, and provide the intended clinical benefit of their manufactured device. Tips for Medical Device Manufacturers to Perform Clinical Evaluation & Literature Research Tip 1: Utilizing […]
Hundreds of thousands of medical devices are manufactured annually across the globe with the intention of providing assistance to those who are struggling with their health. Manufacturers of these devices are supposed to take extra care in the production process. But sometimes due to shortcomings in design, certain errors happen and those people who use […]