Regulatory Services

Post Market

• Notified Body Audit Support

• 483/Warning Letter Responses

• Audit Nonconformity Responses

• Recall Activities

• Advisory Notices

Premarket

• FDA Q Sub

• 510(k) Submissions

• FDA AI Responses

• Global Device Submissions

• NSE Appeals

• FDA GUDID Submissions

• IDE/Clinical Trial Protocol

• Complaint Investigations

• MDR/Adverse Event Reporting

• Post Market Surveillance

• Letters to File

• FDA Inspection Support