Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news.
Sylvie Le Glédic, Sabah Malek
2013 - SCRIP Regulatory Affairs
Sylvie Le Glédic, Director Medical Devices & IVD
Sylvie Le Glédic is in charge of the design and implementation of global regulatory strategies for the development and registration of in vitro diagnostics medical devices (IVDs). Sylvie helps IVD manufacturers in the creation of CE mark technical files and US regulatory dossiers for FDA approval, advising on the required Quality Management System.
Sabah Malek, Senior Regulatory Scientist Medical Devices and In Vitro Diagnostics
She is responsible for multiple client projects involving the implementation of global regulatory strategies and submissions for the development and marketing of medical devices (MD) and on in vitro devices (IVD).