Medical Devices

PDG is your Medical Device Consultant 

PDG’s consultants are experienced in both medical device and combination product development, evaluation, registration and review.  PDG is positioned to help provide assistance and expertise in accessing the U.S. market including help with ISO and GMP quality system compliance, post-market vigilance, distributor qualification and clinical trials.

• Investigational Device Exmptions (IDE)
• Premarket Notifications (510(k))
• Premarket Approvals (PMAs)
• Humanitarian Device Exceptions (HDE)
• Master Files for Devices (MAF)
• Corrective and Preventive Actions (CAPAs)
• Quality System Regulations (QSR) Compliance
• Post-Marketing Safety Surveillance
• Quarterly and Annual Reports
• GMP Regulatory Compliance
• Mock Audits
• Ongoing Reviews of Labeling and "Instructions for Use" Adequacy
• FDA 483 or Warning Letter Response
• Regulatory Consulting