obligated to apply for a CE mark. ... compliant Quality Management System (QMS). ... application and extend the use of t
CASE STUDY PROJECT TITLE
CLIENT
Obtaining CE marking for a medical device
Leading Oncology
manufacturer
Diagnostics manufacturer
BACKGROUND A medical devices manufacturer developed a Class III device to treat a certain type of cancer. The device was designed to use a very specific reagent. The company wanted to develop expand their presence in Europe with this new product and therefore was obligated to apply for a CE mark.
Medical Devices and
REGION
Taiwan / China / Europe
SERVICES PROVIDED Market Research
Regulatory Services Product Registration Business Strategy
PROBLEM In order to obtain a CE mark, the manufacturer must submit an extensive application dossier with scientific and technical data to a Notified Body for assessment. They must also have a compliant Quality Management System (QMS).
OUR SOLUTION Leveraging our technical medical devices expertise and extensive business development approach, Biomedic Consulting proposed to the client to broaden the scope of their CE mark application and extend the use of their device with other more general reagents instead of the one selected by the company.
RESULTS Biomedic Consulting managed the communication with the Notified Body to expand the terms of usage of the device. Biomedic Consulting helped the company to submit the updated information and successfully obtain the CE mark on the first try. Biomedic Consulting helped oversee the implementation of a compliant Quality Management System (QMS). Biomedic Consulting helped the company access a multi billion market in Europe.
For more information about Biomedic Consulting services, contact us at
[email protected] or visit us at www.biomedicasia.com
