英国标准协会BSI：2025年第六十一章第十条基于非临床数据的临床评估白皮书（英文版）

Within the healthcare sector, there are thousands of different types of medical devices, ranging from low-medium risk devices such as wheelchairs, contact lenses, surgical instruments to more complex higher-risk devices such as cardiac pacemakers, heart valves and orthopaedic implants. With rapid advances in technology, the healthcare sector has also seen an explosion in digital medical devices (Software as a medical device) some of which incorporate artificial intelligence and machine learni