MDR & S/AER Reporting Consultants

As part of our FDA consulting services, FDA Compliance Group offers expert assistance with S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting) for all FDA-regulated industries.

Our team of FDA consultants includes industry experts and former FDA employees who have expertise in:

• Dietary supplements
• Pharmaceuticals/OTC
• Medical devices
• Food & beverage
• Tobacco
• Clinical trials

Our MDR & S/AER Services

S/AER and MDR consulting services we provide include best practices for:

• S/AER and MDR submissions
• S/AER and MDR SOP development
• Recordkeeping requirements
• Product recalls, corrections and removals
• CAPA processes
• Full compliance with FDA rules and regulatory actions

Ready to streamline your adverse event reporting? Contact FDA Compliance Group for MDR consulting services.