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- "The ISO auditor complimented your IQ OQ PQ (steam sterilizer and dry heat oven) validations and suggested that we use your document format to develop templates for our other validations."
Director QA/RA, Medical Device Contract Manufacturer, Toronto, ON
- “This has been incredibly helpful. You can’t imagine how important the sterilizer validation and cleanroom training have been.”
Director of Microbiology, Contract Test Laboratory, Denver CO
- “Thank you for all the good work. You're just a protocol-writing machine, with excellent writing skills”
Senior Product Development Engineer, Medical Device Manufacturer, Chicago, IL
- “Professionalism…patience…knowledgeable…personable… weathered the challenges of our sterilizer validation.”
Director of Recovery, Tissue Procurement Agency, Chicago, IL
- “We were both amazed at how incredibly smoothly the whole microbiology project went. We will use your services again.”
QA Director and QC Supervisor, Atrial Stent Manufacturer, Boston, MA
- “You get more done, more quickly, with more practical recommendations than did our former FDA consultant, who charged higher rates.”
Director Quality Assurance, Medical Bandage Manufacturer, Charlotte, NC.
"Your input (EO sterilizer validation) has been extremely valuable and we thank you for your patience."
Senior Regulatory Associate, Venous Catheter Manufacturer, Toronto, ON
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Insuring compliance for your sterilization and microbiology processes
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