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 A key component of this transition is the incorporation of medical device data into larger healthcare systems such as Electronic Medical Records (EMR) and Electronic Health Records (EHR). This article examines how incorporating data from medical devices can improve patient engagement, lower costs, and improve healthcare outcomes. Transitioning from conventional medical care to digital […]
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 […]
Digital health applications are becoming important players in personal healthcare as technology develops and transforms the healthcare sector. These applications make it simple for users to keep tabs on their level of fitness, measure their caloric intake, manage chronic illnesses, and even communicate virtually with medical professionals. By offering personalized insights and suggestions based on […]
The medical device industry is experiencing swift transformation driven by the integration of software, hardware, and healthcare. Connected devices and software as a medical device (SaMD) lead this evolution, offering opportunities to enhance patient care, health results, and operational effectiveness. Despite the enormous advantages that Software as a Medical Device (SaMD) can offer, innovators face […]
Medical device experts who want to learn more about the SaMD risk management approach and its potential applications should use this resource. Your business may improve results throughout the product lifecycle and comply with ISO 14971 with the support of a well-designed and well-executed risk management system. The famous quote from Benjamin Franklin that reads, […]
