Case Study: MDR Consulting Support – Neuro-Oncology & Interventional Radiology Product
Background – Client Needs:
The client is the manufacturer of a Class IIb computer-controlled system for performing non-invasive stereotactic radiosurgery of lesions in the brain, head and neck.
The system consists of both hardware and software components, including a linear accelerator that provides the therapeutic radiation source and a kV imaging system to locate the treatment target.
Project Initiation & Key Objectives:
The manufacturer approached Celegence for regulatory guidance for the device’s initial CE-marking and approval in the EU.
Celegence Solution & Approach:
Celegence supported the client for the following activities for the Class IIb radiosurgery device:
Project Achievements
The device successfully received its CE Mark clearance. The client further extended their partnership with Celegence for the device’s Post-Market Clinical Follow-up report and yearly maintenance-CEPs and CERs.
Project Outcomes
Key to the success of this partnership is the process of involving experienced resources, working in tandem with the client’s regulatory team and specialized in delivering multiple documents in expedited timelines.
