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, […]
Software as Medical Device is a paradigm shift that is changing the way we think about medical technology; it is no longer just a fad. SaMD is becoming more and more important in patient care, from real-time health monitoring to clinical decision support. The choice of a suitable software development technique for medical devices is […]
Age tech is digital technology that has been developed with older individuals’ needs and preferences in mind, involving them in the design process. In a more general context, age tech could refer to any technology that enhances the quality of life for senior citizens. Accordingly, a smart pillbox that will remind her to take her […]
Introduction to SaMD development The Software as a Medical Device (SaMD) market has taken the lead in changing the way we see and use medical technology in the ever-changing healthcare landscape. According to recent market evaluations, the SaMD industry will develop at an astounding rate, with projections showing a market size of $167.59 billion by […]
