Françoise Schlemmer Director of Team-NB
Administrateur at Quasys Consult
After a master's degree in biochemistry, she worked for Medical Device Manufacturers, a Notified Body and set up Quasys Consult consultancy.
Quasys Consult mainly helps manufacturers of medical devices to obtain the CE mark.
Since 2001, she is director of TEAM-NB, an association that brings together 26 notified bodies in the medical devices sector. These members issue more than 80% of the certificates worldwide. In this context, she attends meetings under the aegis of the European Commission.
She conducts conferences on the trends of the new European regulations.
TEAM-NB is an AISBL created in 2001. It now has 26 members (http://www.team-nb.org/
This association’s aims:
Encouraging the continuous improvement and development of products, allowing patients increased access to safe yet innovative devices.
Active involvement and support on the implementation of the new Medical Device Regulation and the In-Vitor-Diagnostic Regulation, e.g. by supporting the creation and pragmatic update of guidances
Support to notified bodies, through our detailed and state of the art guidance documents, to ensure a harmonious standard is achieved by our members throughout Europe.
The promotion of innovation, but innovation that is backed by solid safety and effectiveness data. The certification of manufacturers’ products is essential to continue the confidence in Medical Devices and In-Vitro Diagnostic products.
Develop effective communications to ensure our members receive the latest information on all regulatory developments, including guidance, regulations and standards.