ORA innovations boasts over 30 years of combined experience in Quality Management Systems, Compliance, Project Engineering, Product Development, Auditing, Training, New Product Introduction, Documentation and Manufacturing for diverse industries from Electronic Equipment, to Medical Devices and Pharmaceuticals.

With a wealth of experience in Implementing, Auditing and Managing Quality Management Systems ORA innovations has led a number of Medical Devices Companies to achieve their certification to ISO13485, CE Mark their products and others to ISO 9001.

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Product Development & Documentation

ORA provides expert advice on:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • New Product introduction from design to manufacturing

  • Product and Process FMEA & PFMEA

  • Process Validation

  • Product Realisation Risk Management