Practice Area Focus
- Regulatory Affairs
- EU Regulatory Strategy
- TGA Regulations
- Clinical Evaluation Reports (EU and TGA)
- Post Market Surveillance – Vigilance Reporting/PSUR
Daniela Sanders joined NDA Partners as an Expert Consultant in 2018. She is a medical device consultant with extensive experience in regulatory issues, particularly in Europe and Australia, and in strategic planning and the preparation of medical device and combination product applications to gain marketing approval worldwide. She is a specialist in Clinical Evaluation Reports (CERs) for Europe and Australia (all classes, implantables, and combination devices) and can assist with the preparation and QC of these reports in preparation for submission.
Ms. Sanders was formerly Team Leader of Regulatory Affairs and Senior Regulatory Affairs Officer at Cook Medical in Queensland, Australia.
In addition to her medical device experience, Ms. Sanders served as a US FDA Drug Safety Evaluator for Cardio-renal drugs in the Office of Drug Safety at the Center for Drug Evaluation and Research (CDER). Prior to this, she was a Project Officer for the implementation of the Australian Pharmaceutical Advisory Council (APAC) National Guidelines for the Continuum of Care of Medicines between Hospital and Community; and a Research Clinical Pharmacist for Brisbane Cardiac Consortium-Clinical Support Systems Program (BCC-CSSP) in Queensland, Australia.