| Regemon consultants provide practical solutions and work with you to develop and implement effective regulatory strategies, prepare domestic and international regulatory submissions, manage FDA and foreign regulatory agencies (EU Notified Bodies, HC, MHLW, SFDA) inspections and train your employees in all aspects of regulatory compliance.
Product Compliance
- FDA Premarket submissions: 510(k)
- International submissions: Technical Documentation under EU MDR, Health Canada- Class III and IV Submission Files, STED
- Device classification
- Product modifications strategies
Post-Market Compliance
- Product-specific compliance strategies
- Complaint Handling- Evaluation, investigation and documentation
- Preparation of FDA Adverse Event Reports (MDR)
- Preparation and submission of EU Vigilance Reports
Resolving Regulatory Problems (Crisis Management)
- FDA Enforcement Action resolution
- Warning Letter remediation services
- FDA Inspection: prepare 483 response
- Notiifed Body: prepare audit response (root cause, corrections, corrective actions)
- Global product recalls incl. communication with FDA and international regulatory agencies
- Responding to questions from Notiifed Bodies and/or FDA
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