Our client is the distributor of a medical device manufactured outside of the EU. The manufacturer holds regulatory certification for the device. The product is currently classified as a class 1 medical device, however the competent authority recently informed our client that the product needs to be re-classified as a class 2a device. Our client asked us to support them in making this transition. We began by undertaking a Gap Analysis to understand what documentation was missing and needed to be generated. This was following by a second phase of work to compile a Technical File appropriate for the product, and the identification of a Notified Body able to undertake the re-classification. Later phases of work are being planned to complete the re-classification.
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