Latest From Cetas Healthcare

Introduction: In vitro diagnostic (IVD) devices play a pivotal role in healthcare, aiding in the diagnosis, monitoring, and management of diseases. With the continuous advancement of technology and an ever-expanding IVD market, ensuring the safety

Introduction: Long-term clinical data is essential for understanding the performance, safety, and overall effectiveness of medical devices over an extended period. Some key reasons why Long-term data is important for medical devices: 1. Detecting Long-Term

Introduction: Brand tracking is a systematic process to evaluate the health of a brand over time. It’s an ongoing assessment that measures the consumer perception of a brand, typically conducted one or two times a

Introduction: Post-Market Clinical Follow-up (PMCF) surveys have become a vital tool for ongoing assessment and validation of device performance and safety. The integration of ISO 14155 guidelines into PMCF activities offers regulatory professionals a robust

Introduction: A well-designed questionnaire is one of the most critical aspects in the execution of Post-Market Clinical Follow-up (PMCF) surveys. These surveys ensure that your medical devices continue to perform as intended and remain safe

Introduction: The healthcare industry is rapidly evolving and one of the key drivers of this transformation is Artificial Intelligence (AI). To stay competitive, MedTech firms must stay ahead of the curve in AI adoption with

Introduction: In the dynamic arena of medical device regulation, clinical evaluations play a pivotal role in assessing the medical devices’ safety, performance, and effectiveness. A crucial component of a comprehensive Clinical Evaluation Report (CER) is