Complete Quality System

Documentation Package includes the following Standard Operating Procedures and accompanying forms for supporting processes, establishing requirements and product records:

• Quality Manual

• Document Controls

• Quality Records

• Management Responsibility

• Design Controls

• Software Development Life Cycle

• Training

• Risk Management

• Control of Inspection, Measurement, Manufacturing, and Test Equipment

• Supplier Management

• Material Receiving and Verification of Purchased Products

• Receiving and First Article Inspection

• Purchasing Controls

• Identification and Traceability

• Material Transfer, Storage, and Control

• Shipping and Distribution

• Sterilization

• Lot Release

• Corrective and Preventive Action

• Returned Goods Authorization

• Complaint Handling

• Quality Audits

• Production and Process Controls

• Process Validation

• Statistical Techniques

• Control of Nonconforming Materials

• Customer Order Fulfillment

• Clinical Adverse Events Management

• Clinical Operations Procedure

• Postmarket Surveillance