Each company is unique. One-size-fits-all approaches will never help your business reach its full potential. We deliver custom solutions, tailored to you – your industry, your culture, your one-of-a-kind challenges. We support remediation of Sterility Assurance challenges. Validations for Ethylene Oxide, Steam / Moist Heat Sterilization, Radiation, and Aseptic Processing. and packaging. 

We offer a wide range of Sterilization and Medical Device consulting services, all designed to help your company reach its goals and potential. Whether you're looking for advice or complete validation we have you covered. Our services are available a la carte so you can get precisely what you need. Our Mission is your success.  

EXPERT ASSISTANCE 

In​ development of Medical Device products for sterilization, sterilization process design, material compatibility, process deviations, failed validation, just to mention a few. 

WELCOME! 

OUR APPROACH

What We Do

​​​​​​​​Sterilization and Quality System Consulting LLC

​​STRATEGIC PLANNING   

Crafting a product compatible sterilization process validation for product and packaging design through  end of product shelf life. 

RISK MANAGEMENT

Knowledge of the regulatory risk assessment environment and applicable standards and practices insures compliance.