Eliminating risk and securing scalable growth with robust OTA update capabilities
On a mission to facilitate and promote sustainability throughout the energy transition, Octave Energy, a Belgian leader in smart and flexible energy solutions, offers both first-life battery systems and repurposed end-of-life batteries from electric vehicles as energy storage sources. The Octave Energy in-house Energy Management System intelligently manages battery systems, solar panels, and charging stations to enable smart, sustainable energy use and build a cleaner, brighter future.
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.