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
Welcome to the dawn of 2023’s dentistry future, where revolutionary trends are reshaping the industry. This year, the dental sector is undergoing a profound transformation fueled by technology and evolving patient preferences. Here are the
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
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