Regulatory Training

• Awareness and Implementation MDR 2017 G.S.R 78 E
• Performance Evaluation IVD
• Risk Analysis ISO 14971:2019
• Regulatory Orientation (Medical Devices)
• CE Marking: MDR 2017-745. Medical Devices
• CE Marking: MDR 2017-746. IVD
• Medical Device Regulatory Fundamentals/ Regulatory Orientation
• Medical Device Quality Management Systems (QMS) Implementation
• Medical Device Risk Management Training: ISO 14971:2019
• Medical Device Regulatory Submissions
• Post-Market Surveillance and Vigilance
• Medical Device Labeling and Packaging Compliance
• Good Manufacturing Practices (GMP) for Medical Devices
• Medical Device Auditing and Inspections
• EU Medical Device Regulation (MDR) Training CE Marking: MDR 2017-745. Medical Devices/ CE Marking: MDR 2017-746. IVDs
• FDA Medical Device Regulations Training
• Clinical Evaluation and Clinical Trials for Medical Devices
• QSR 21CFR Part 820
• MDSAP

Ready to enhance your regulatory knowledge and expertise? Join us at PRNS Academy and embark on a journey of regulatory excellence. Explore our diverse range of training programs, connect with our expert instructors, and gain the skills and confidence needed to navigate the complex world of regulatory compliance.