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 world is on the brink of a demographic shift, with around 10,000 people in the US turning 65 years old every day, a trend that is expected to continue for the next decade, according to AARP. This transition will result in older adults accounting for over 20% of the population, leading to a greater […]
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 […]
As technology continues to advance and revolutionize the healthcare industry, digital health apps are emerging as a key player in personal healthcare. With the help of these apps, individuals can easily monitor their fitness levels, track their calorie intake, manage chronic diseases, and even connect with doctors on a virtual platform. These apps are designed […]
In today’s technology-driven world, the healthcare industry is continuously adopting digital solutions to enhance patient care and optimize operational efficiency. Custom healthcare software development has become increasingly popular among healthcare organizations seeking to automate their processes and provide individualized patient care. Healthcare software development refers to computer programs or applications that support healthcare-related processes, workflows, […]
Introduction Software as a Medical Device (SaMD) is a rapidly growing field that offers advanced diagnostic and therapeutic solutions to patients. With the increasing use of SaMD in healthcare, there is a need for stringent risk management to ensure patient safety. ISO 14971, an international standard for risk management in medical devices, provides a comprehensive […]
In the rapidly evolving healthcare industry, Software as a Medical Device (SaMD) has emerged as a transformative element, significantly altering the landscape of medical device technology. SaMD has gone beyond being a mere trend; it’s a paradigm shift that’s reshaping how we approach medical technology. From monitoring patient health in real-time to supporting clinical decisions, […]
Introduction to SaMD Development In the dynamic landscape of healthcare, the Software as a Medical Device (SaMD) segment has emerged as a trailblazer, reshaping how we perceive and interact with medical technology. Recent market analyses forecast staggering growth in the SaMD sector, with predictions of reaching a market valuation of $167.59 billion by 2032, marking […]
