Biomedical Engineer and Regulatory Affairs Specialist at MRG with hands-on experience in ensuring compliance of medical devices with SFDA regulations and international standards. Skilled in regulatory submissions, quality assurance, and compliance processes, with a strong understanding of IVD and medical device requirements. Adept at navigating complex approval pathways to support the timely and safe introduction of medical technologies to market.
planed preventive maintenance (PPM) and Corrective Maintenance.
Learning basic design methods of electrical circuits using LabVIEW and Multisim.
3d printing.
Learning soldering electric circuits components and PCB diagrams using Multisim.
A low-cost prosthetic transradial arm controlled by an EMG sensor with a proximity sensor at the finger tips for grasping.
American heart association (BLS)
ISO 13485:2016 - Quality Management Systems for Medical Devices
Medical Technology and Evaluation
Operations and Patient Safety for Healthcare IT Staff.
ENSURING SAFETY IN MRI ENVIRONMENTS
First place award on BTEC_2024 for my senior design project.