Veteran Owned Business

FQE, LLC

From product to process validation we can assist your company in meeting FDA and ISO requirements.


Validation

We have experience validating medical devices as well as medical device processes.

Our experienced personnel will either gather or work with you to gather user requirements and assess your system to ensure that it is designed and tested to operate as intended.

We follow a simple Validation Life Cycle Approach as displayed.


We can create a Master Validation Plan (VMP) or assist you in developing a VMP to guide you through your validation process.


Our support includes designing User Requirement through authoring Validation Summary Reports so your product can hit the market as planned.