Overview:
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speakers
Eyal Lerner,
Who Should Attend
- Medical Devices Quality Personal (QA and QC)
- Laboratory Managers
- R&D Researchers of Medical Devices and Combined Products
- Quality Control Staff
- Regulatory Affairs (RA) Staff
