Clinical investigations are crucial in the process of bringing a medical device to market. Although they are often seen as challenging and complex, having a solid understanding of the relevant standards can simplify the experience. Familiarity with ISO 14155:2020 is vital, as it serves as a guide for Good Clinical Practice (GCP) in clinical investigations […]
Introduction to EU MDR The European Medical Device Regulation (EU-MDR) 2017/745 took effect on May 26, 2021. It replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). This newer framework introduces more demanding requirements to bolster product safety, performance, and post-market tracking. Medical device manufacturers must create an EU MDR […]
Another event that will take place in Split is the Healthtech Adria Conference 2024. Presented by the Croatian healthcare technology development business accelerator NetHub in association with the University of Split School of Medicine, this conference will include interactive demonstrations, lively discussions, and a startup pitch contest. About Healthtech Adria Conference 2024 A vibrant mix […]
Patient-centred design requires a new way of doing things. That means saying goodbye to paper and moving into the 21st century. Integrating information technology (ICT) solutions in healthcare enhances patient care and experience. It increases accessibility to health information and improves patient outcomes. A factor contributing to the success of ICT in healthcare is patient-centered design (PCD). […]
Overview Medical device data integration has become a pivotal element in patient care, introducing an era where healthcare providers and patients can access information in real time. In the past, healthcare professionals depended mostly on in-person appointments to obtain health data. This made it difficult to spot subtle changes in a patient’s condition between visits. […]
Regulatory affairs specialists are leading the charge in clinical research to ensure adherence to the rules and regulations established by regulatory bodies like the Pharmaceuticals and Medical Devices Agency (PMDA), the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and the Food and Drug Administration (FDA). Their proficiency is crucial for […]
What is EUDAMED? EUDAMED serves as the European Database on Medical Devices. It resembles other public government databases, such as the US FDA’s database, housing all registered Establishments, 510(k)s and pre-market approvals, device listings, adverse events/recalls, clinical investigation data, and more. EUDAMED is intended to centralize medical device and IVD information into a single databank, […]
The medical device manufacturing industry is experiencing significant growth worldwide, with contract manufacturing playing a crucial role in this expansion. Over the past few decades, this sector has evolved to meet increasing demand and reshape medical technology. The European medical device market is the second largest region globally and is projected to grow at a […]
In 2024, the European Database on Medical Devices (EUDAMED) is set to undergo significant changes that will impact the registration and monitoring of medical devices within the European Union. Manufacturers, authorized representatives, and other stakeholders in the medical device industry must familiarize themselves with these changes and make the necessary preparations to comply with the […]
The concept of the patient digital twins stands out as a beacon of innovation with the potential to redefine personalized medicine and patient care. This approach leverages advanced biophysiological data models and algorithms to create a digital simulation of a patient’s health, offering unprecedented insights into their current and future medical needs. As we delve […]
