Regulatory Affairs

Canopy Medical offers Regulatory Affairs services to companies involved in medical device product development and world-wide product launch. These services include, but are not limited to:

Regulatory Affairs

• FDA Regulatory Submissions; pre-IDE, pre-IND, IDE, IND, BLA, PMA, 510(k) (including deNovo), Orphan Drug HUD, Certificate of Suitability
• MDD Design Dossier, Technical File development for CE Mark
• International Registrations: Medical Devices, Drugs, Combinations & Biologics & Combinations
• Medical Device Reporting (MDR) & Medical Device Vigilance (MDV) system
• Drug Master File Development and Management
• Surveillance of Global Issues Effecting Industry
• Device Labeling Development and Review
• Marketing Materials Review for FDA compliance (including Websites)
• Global Regulatory Strategic Planning
• FDA PMA Panel Preparation, Medical Device Dispute Resolution Panel
• Quality Management System (QMS) training & development for Start-up
• Regulatory Affairs and Clinical Affairs for Start-up
• Audits for Japanese GCP, FDA QSR, cGMP (21 CFR 211, 600, 610 & Q7A) & EN ISO 13485
• Technical Writing for IDE and IRB submissions

Special Topics

• Risk Analysis for Products containing animal materials (biologics)
• EMI / EMC Labeling Requirements
• MRI Labeling Requirements