Series
A systems approach to navigating UK regulatory pathways
3 chapters • 30 min read
Mapping the five UK regulatory subsystems—MHRA, NICE, DTAC, data protection, and procurement—and identifying leverage points for competitive advantage
MHRA registration, clinical evaluation, software/AI pathways, NICE evidence generation, and NHS DTAC requirements
ISO 13485 quality management, acceleration strategies, post-market surveillance, and case studies from Sleepio, Skin Analytics, and Doccla
