Medical devices
10 December, 2020
Case Studies
Medical devices
Case Studies
Situation
Our client was undertaking the development of a medical device but unfortunately had no internal resources to manage the development and CE marking procedure to what was a tight schedule.
Challenge
We had to carefully identify and manage a group of expert suppliers for the processes of manufacturing, biocompatibility studies, the clinical study and make the selection of the notified body who was supporting the process. All within the scheduled timelines defined by the client.
Solution
Assion selected the network of suppliers to be involved from an established and consolidated network.
We then developed a detailed plan that was agreed with the client and all involved parties. It was then a process of managing the development steps and prepared the technical file for submission to the notified body. Assion were in control of managing the complete project process up to the CE Marking.
Benefits
Our client was able to benefit from the known Assion network capabilities, the expert project management of ourselves and our network. Our regulatory expertise, together with the practical implementation of all of the required tasks allowed the client to reach their objectives of achieving a CE Marking within their planned deadline.