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Guiding Principles of ISO 14155 for Post-Market Clinical Follow-up (PMCF) Surveys for Medical Devices

Guiding Principles of ISO 14155 for PMCF Surveys for Medical Devices

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

Post-Market Clinical Follow-up (PMCF) surveys - medical devices, Crafting an Effective PMCF Survey

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

Market research, MedTech and Artificial Intelligence (AI) in 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

Enhancing Clinical Evaluation Report (CER) medical devices

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

Dental Market - Artificial Intelligence: Revolutionizing Diagnostics, Innovations in Dentistry

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

MedTech Marketing Research methodology - Medical devices, 5 Key Areas

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

Post-Market Clinical Follow-Up (PMCF) medical devices, Leveraging Retrospective

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,

post-marketing surveillance (PMS) medical device, Synergizing Proactive and Reactive

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

European Union Medical Device Regulation (EUMDR) and Vitro Diagnostic Medical Devices Regulation (IVDR)

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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