Incorporating Software in Combination with Medical Devices Hardware
Published Dec 04, 2023
Published 04th December 2023
Recent advancements in Artificial Intelligence (AI) have impacted the evolution of medical device technology making it more precise, efficient and effective. This whitepaper explores the use of Artificial Intelligence as it is applied to medical device technology, discussing the benefits and challenges posed. Regulatory authorities recognise the need to provide guidance on safe development and maintenance of medical devices incorporating Artificial Intelligence to manufacturers. The whitepaper reviews the dynamic regulatory landscape for these products, where regulators are in the process of developing key principles, standards and guidance.