Validation Studies

MDRA can help your company with the following:

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

Validation studies are an important aspect of the process during the design and development of any device.  Since many device designs occur prior to and during this stage, it is important that manufacturers who intend to commercially produce the device follow adequate design control procedures, including validation and verification.