Date: 28th of May 2024
Time: 14:00h - 18:00h CEST | 9am - 1pm EST
Location: Virtual
Language: English
Costs: € 595,- | $ 643.-
Introduction
Providing participants with a comprehensive understanding of the Quality System Regulations (QSR) and registration and certification of (in vitro) medical devices in the USA.
The course aims to equip quality assurance, quality control, regulatory, manufacturing, marketing personnel, senior management and investors with the necessary knowledge and skills to navigate the complex regulatory landscape governing medical devices in the USA, whether those medical devices are well established or incorporate truly innovative technologies.
Specifically, the objectives may include:
- Understanding Quality System Regulations (QSR): Ensuring participants grasp the requirements outlined in QSR to maintain quality standards in the manufacturing and distribution of medical devices.
- Navigating Regulatory Pathways: Educating participants on the various regulatory pathways available for bringing medical devices to market, including the processes, requirements, and compliance standards involved.
These objectives aim to provide a holistic understanding of QSR, regulatory pathways, and compliance standards within the medical device industry, ensuring that participants are well-equipped to navigate and comply with the regulatory framework governing medical devices.
Trainer: