Latest From Cetas Healthcare

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

Concept testing is a fundamental Marketing Research methodologyprimarily used to assess customer feedback onnew product/service ideas or concepts. It is a great evaluation tool to determine whether a company should move forward with a product

Introduction: In the dynamic space of the medical devices world, ensuring their safety and effectiveness post-market is paramount. Post-Market Clinical Follow-Up (PMCF) studies play a pivotal role in this endeavor. Among the various PMCF approaches,

Explore Clinical & Regulatory Services Introduction: The convergence of proactive and reactive methodologies within a post-marketing surveillance (PMS) system can significantly enhance the effectiveness and robustness of medical device monitoring. By harmonizing these approaches, manufacturers

Introduction: ‘Sufficient clinical data’ is a critical term used in the context of medical device regulations to describe the level of evidence required to demonstrate the safety and performance of a medical device. It refers

Introduction: The EU Medical Device Regulation (MDR) is a set of regulations that govern the safety and performance of medical devices in the European Union. The MDR is one of the strictest medical device regulations

Medtech companies are expected to play a key role in the digital transformation of healthcare. Many are already prioritizing building digital capabilities in-house via investing in R&D, business models, and acquiring assets to expand their