Validation and Quality Control

DQ IQ OQ PQ Validation
Standard Operative Procedures (SOP) (IOP)
Technical file
Risk Analysis           

Design & Engineering

We are able to define the different types of tests specific to the material and for the device to validate. We carry out and coordinate activities related to:

• Mechanical test 
• Test on Polymers 
• Biological Safety Evaluation 

We assist our clients in all phases:

• Definition of specific tests for the validation of a new device. 
• Selection of test conditions. 
• Critical Analysis of the related Standards. 
• Analysis of Regulatory context. 
• Definition of Acceptance Criteria. 
• Normed Test Execution. 
• Definition of Sample Numbers. 
• Statistical Analysis of the Results. 
• Critical interpretation of the Results.

We are able to coordinate testing activities at all stages.