Navigating FDA and MDR Compliance: Managing the Device Lifecycle and Embedded Software Updates in Medical Devices - Dr. Baya Oussena
Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the Medical Device Regulation (MDR), ensure the safety, effectiveness, and quality of medical devices. For software-driven devices, compliance is an ongoing process; each update or modification can present regulatory challenges for manufacturers. The rapid pace of software innovation makes navigating regulations more complex. Proactively addressing these challenges enhances quality, improves reliability and safety, and adds value for both patients and healthcare providers.
Preparing for the U.S Food and Drug Administration (FDA) premarket and 510(k) submissions
Expanded health access with telemedicine and digital health solutions; personalized healthcare and advanced detection and monitoring for improved patient outcomes. Operational efficiencies through automation, digitalization, and entirely new workflows. Promising cutting-edge Internet of Medical Things (IoMT) and AI-powered solutions tackling today's most challenging issues. For the medical and healthcare industry, technology holds massive untapped potential. Yet, it also comes with novel challenges.
Decarbonizing the future through a future-proofed OTA update infrastructure
In today’s modern connected world, transitioning to sustainable energy is the cornerstone of all the technologies enjoyed and relied upon daily. Aiming to progress alternative energy solutions and reduce the reliance on fossil fuels, a European battery technology innovator, steps in with a bold and simple plan to enable the future of energy by developing a sustainable battery cell out of their main plants in Europe.