We were asked to support a young medical device company in its aim to achieve a CE Mark and FDA clearance for a Class III medical device wound care product.
A young wound care company asked us to provide senior input to assist them in achieving regulatory clearance for a Class III medical device in Europe and the USA. We were asked to assist the company in: selecting a contract manufacturing organisation (CMO); selecting a contract research organisation (CRO); transferring its technology and processes to the CMO in order to manufacture clinical trial batches of product; choosing clinical trial sites and designing the clinical trials; applying for a CE Mark for the product. This involves our team being closely integrated with the client’s team throughout the process.
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