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.
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.
Robust & secure over-the-air updates for medical & healthcare devices
To realize the massive potential of new technology, medical and healthcare device OEMs must embrace modern, purpose-fit infrastructure. Advancing patient outcomes requires innovation, and innovation in a software-centered world requires robust and secure over-the-air (OTA) updates. Without it, innovation and, thereby, progress fail.