"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, Ontario.
“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
“The lead (ISO) auditor was very complimentary about the full validation. His comment was "Written in plain English, covered all the ISO bases, and very well documented." He went through the books and didn't have a single question” Thank you.
“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.” and "I have to say that I really enjoy working with you. You always approach a problem in a logical and practical way that I can understand. Thank you!"
Director Quality Assurance, Medical Bandage Manufacturer, Charlotte, NC.
"Your input (EO validation for 510k) has been extremely valuable and we thank you for your patience."
Senior Regulatory Associate, Venous Catheter Manufacturer, Toronto, ON
"I'm not worried about our sterilizer (autoclave) validation, it's solid as a rock"
General Manager, Contract Test Laboratory, Denver CO
"Our ISO auditor was very pleased with the format and the content of the EO validation protocol & report"
Director Product Development, Laparoscopic Instrument Manufacturer, Denver CO
Insuring compliance for your sterilization and microbiology processes
Medical Device Consulting - Sterilization and Microbiology