Smith Associates

Experienced Consultants Specializing in Regulatory Affairs:

• 510(k) Submission (Pre-Market Notification)

• PMA (Pre-Market Approval)

• IDE (Investigational Device Exemption)

• (cGMP) Quality System (Good Manufacturing & Quality Assurance)

• Medical Marketing Services

• Warning Letter Response

• Device and Cosmetic Labeling

• United States Agent/Official Correspondent Services