Our client asked us to develop a CE marking strategy for medical imaging software.
Our client, a USA based start-up company, is developing software that uses machine learning and artificial intelligence (AI) to enhance the accuracy of medical imaging diagnostics. This software helps to improve the sensitivity of mammograms and improve the diagnosis of breast cancer.Â Our client wished to launch the product in Europe and commissioned Alacramed to develop a CE marking strategy. We proposed a classification for the device and a route to conformity, developed a plan for implementing an ISO13485 quality management system, referenced the appropriate standards, and listed the documentation requirements for CE marking. We presented this in an overall project plan that included activities, and estimated timelines and costs.
We are a specialist medical device consultancy consisting of industry experts with long and successful track records in commercialising medical device products. We have broad functional and sector experience, and would welcome an opportunity to discuss with you any challenge relating to creating sustainable value from medical technologies.
Munna Choudhury of Alacramed will be attending UK BIOTECH SUMMIT 2019, on
Mark Wickham of Alacramed will be attending Med-Tech Innovation Expo 2019 at
We understand the need for accurate, tailored health economic and budget impact
Alacramed Ltd, St Johns Innovation Centre, Cowley Road, Cambridge,
+44 (0) 1223 421885