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Introduction: Once upon a time, MedTech companies could afford to be sales driven organizations on the back of their engineering prowess. Alas, those days are now over. MedTech companies face a consistent challenge of distinguishing
Introduction: The European Medical Device Regulation (EU MDR 745/2017) has significantly enhanced the regulatory framework governing medical devices in the European Union (EU). Among its many provisions, incident reporting stands out as a crucial aspect
Introduction: In the ever-evolving landscape of healthcare technology, new product development and commercialization of Medical Devices can be a daunting task. One of the greatest challenges faced by product management and marketing leaders in the
Download the Full Report Cetas Healthcare As the MedTech industry continues to evolve at an unprecedented pace, professionals across the sector are keenly observing emerging trends that promise to reshape healthcare delivery, patient engagement, and
Introduction: Post-market clinical follow-up (PMCF) data plays a crucial role in ensuring the long-term safety and effectiveness of medical devices. While the Clinical Evaluation Report (CER) forms the foundation for pre-market approval, it inherently relies
Introduction: The MedTech industry has evolved significantly over the years, with innovations driving the development of life-saving devices and diagnostics. In this era of precision medicine and evidence-based healthcare, the demand for robust data to
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
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