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Medical Device Consulting ---
Consultant for Sterilization, Sterilizer Validation, and USP / AAMI Microbiology
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Mark Dott LLC Consulting Services provides skilled consulting in the areas of sterilization, ISO sterilizer validation, and the validation of GMP microbiology test methods. This includes Ethylene Oxide / EO, Steam, Gamma, and Sterrad processes, and the validation of numerous USP / AAMI microbiology test methods.
Over twenty-five years experience includes medical device (also instruments, sets, and kits), surgical implant, surgical disposable, human tissue / HCTPs, biologicals, combination products, and contract test laboratories.
Mr. Dott is also a Certified Industrial Sterilization Specialist / CISS per the Association for the Advancement of Medical Instrumentation, 2018.
Experienced…professional…thorough. When compliance is your priority, call us.
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| Sterilizer validation of Ethylene Oxide / EtO, Steam (autoclave), Gamma, and Sterrad (hydrogen peroxide) processes per published ISO or AAMI standards. Mr. Dott has validated, supervised, and/or operated all these processes. Advice on sterilization processes. Prepare validation protocols, execute validation activities, solve problems, review results, prepare final reports, train employees. Preparation of SOPs, establish product families, new product introductions, etc. |
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Validation of microbiology laboratory operations and USP / AAMI microbiology test methods including BI testing, USP sterility, bioburden, steam re-sterilization validations, disinfectant - cleaning validation, cleanroom operations & aseptic techniques, etc.
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ph (303) 437-4946 or click Contact Us
Insuring compliance for your sterilization and microbiology processes
EO sterilization consultant
Steam sterilization consultantGamma sterilization consultant
Microbiology consultant
Medical device sterilization
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