Regemon provides customized in-house training for individuals, small or large groups, organizations’ management or production personnel working in FDA- or ISO-regulated environment. 

FDA Regulations

• 21 CFR 820 Quality System Regulations
• Quality System Regulations for Management
• FDA Inspection Preparation
• CAPA process and effective Root Cause Analysis
• Complaint Handling and 21 CFR 803 Medical Device Reporting
• 21 CFR 806 Corrections and Removals (Recalls)
• Preparation for FDA and foreign inspections

International Regulations/ Standards

• CE Marking: Regulation (EU) 2017/745 [MDR] replacing EU Directives for Medical Devices (MDD/ AIMD)
• Canadian Medical Device Regulations
• Japanese PAL
• EU Vigilance Process
• Internal auditing: FDA QSR and ISO 13485
• ISO 13485: 2016 Quality Management System
• ISO 14971: 2012 Risk Management
• Preparation for FDA and Foreign Regulatory Bodies Inspections 

Training Services- In-house courses

• European Union Compliance Process and Regulatory Affairs¹
• Global Awareness: European Medical Device Regulations ¹

¹⁾ The instructor is a former faculty member at Northeastern University in Boston, MA where he taught graduate-level courses offered
    under the Masters Degree in Regulatory Affairs program.