US Agent

• US Agent for International FDA Registration and Listing
• International partnerships make possible market entry around the world

FDA Submissions

• Traditional, Special and Abbreviated 510(k) Pre-Market Notifications
• Regulatory Strategic Plans and Product Classifiction Assesment
• Pre-Market Approvals and Clinical Studies
• Establishment Registration
• Product Listings

Validation Studies

• Product and Process Validation Studies
• Software Verification and Validation
• Sterilization Validation
• Validation Master Plans
• Protocol Preparation
• Validation Report Preparation
• Data Reduction and Statistical Analysis

Quality Systems

• Quality System Regulation (QSR) Compliance Audits
• ISO Quality Manual and Procedure Preparation
• Quality System Improvement Programs
• Independent Supplier Approval Audits
• Design Controls Program Assitance
• Product Risk Analysis

CE Mark

• International Regulatory Strategic Plans
• Product Classification Determination Assistance
• Pre-assessment and Gap Analysis Audits
• Preparation of Declarations of Conformity
• Preparation of Essential Requirements
• Preparation of Technical Files
• Translation Services