Epstein Associates provides services such as the preparation and submission of 510k pre-market notification to the FDA for approval as well as project management.  We manage regulatory affairs, document control, and complaint handling procedures.  We provide consulting services related to FDA medical device policies and procedures, recall advice ad assistance, CAPA, risk assessment and combination products support.

• PMA (Premarket Approval) 
• 510(k) Submission (Premarket Notification) 
• IDE Investigational Device Exemption
• IND 
• GCP 
• Humanitarian Use Devices 

Links:

• Health & Medical Devices News: http://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm
• Latest FDA News: Acetaminophen and Liver Injury: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm168830.htm
• Medical Device Industry Headlines: http://www.devicelink.com/newsedge/  
• US FDA Medical Device Approvals: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm081872.htm