Process Validation

Silicone Molding Process Validation 

Incorporating Validation from the Process to the Part

FMI provides part process part validation, in accordance with FDA and medical device OEM guidelines related to medical device development and production. This can include equipment and software validation as necessary as well. 

Through process validation, FMI demonstrates that the process produces consistent results and quality and meets the product’s critical specifications. 

Our strategy, unique in the silicone-molding field, is to achieve total part validation – through GR&R studies, rigorous validation activities, ongoing production controls, and 100 percent inspection of finished parts – so that our clients can eliminate their incoming inspection at their site, if they choose. 

Process Validation Tools Employed at FMI

  • Measurement System Analysis (MSA)
  • GR&R
  • Part Characterization and Qualification (IQ/OQ/PQ)
  • Design of Experiments (DOE)
  • Process Failure Mode Effects Analysis (PFMEA)
  • Control Plans

ISO_13485_Medical_Devices_MONO_NO_SAI