Medical Device Validation

Validation

To guarantee that we can consistently produce products that meet customer requirements, Orchid is committed to validating all manufacturing processes according to established guidelines of the medical device industry.

Following the Orchid Validation Master Plan (VMP), our team of trained Quality Engineers develops specific validation protocols and conducts validation to confirm that processes are operating within specified limits and quality products are consistently manufactured.

Verification that all equipment is installed and operating properly (IQ)  
Ensure that equipment is capable of delivering the specified process within defined parameters (OQ)  
Confirm that the process can produce products that meet all requirements consistently over time (PQ)  
Validations are performed as necessary during new product implementation  
Processes are re-validated as necessary  

 

 

 
 
 
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