Microbiology & Sterilization
Consulting Services
Microbiology and Sterilization
Consulting for Manufactures
Microbiology and sterilization consulting services are available for a wide range of quality system needs for both medical device and pharmaceutical manufacturers. This includes establishing, maintaining or remediation of entire quality systems or specific clauses. Our staff has decades of industry experience with the following from both an industry and Notified Body perspective:
CFR 211
CFR 820
ISO 13485:2016
ISO 9001:2015
Technical Microbiology and
Sterilization Consulting
Technical microbiology and sterilization consulting is available for all modes of sterilization as well as supporting microbiology processes, including bioburden, environmental monitoring and other assays. We can help with process development, optimization and remediation activities as well as selection and approval of vendors and ongoing supplier quality activities.