Mollie Holter
Consultant & Lead Auditor, Medical Device Sterilization, Microbiology, Biocompatibility, Toxicology
- MicroBio Consulting, LLC
Principal Consultant, Certified Lead Auditor, & Founder of MicroBio Consulting​
Over 25 Years of Quality & Regulatory experience, from laboratory to management
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Expert in microbiology, sterilization, biocompatibility, and toxicology
Industries: Cannabis Products, Medical Devices, Tattoo Inks, Cosmetics, Pharmaceuticals, Nutraceuticals, Biologics, Sterilants, In-Vitro Diagnostics
• Microbiology • Sterilization • Biocompatibility • Toxicology • Regulatory Requirements
• International Standards • Risk Management • Material/Product Requirement Specifications • MDR Compliance • CAPAs • Verification/Validation • Good Laboratory Practices (GLP)• Labeling • Cleanrooms • Lab Design • Management • Project Management • Technical Writing • Good Manufacturing Practices (GMP) • Certified Lead Auditor
Biocompatibility:​
Biological Safety Evaluations​
Biocompatibility Evaluation Plans/Protocols/Reports​
Chemical Characterization​
Toxicological Risk Assessments​
Gap Assessments and Remediation​
Regulatory Compliance (EU MDR)​
Microbiology/Sterilization:​
Cleaning, Reprocessing, Disinfection, and Sterilization​
Microbiological Investigations​
Lab Design and Testing Coordination​
Cleanrooms and Controlled Environments​
IQ/OQ/PQ
Expertise:​
Deep and broad experience in Medical Device Industry​
ISO/AAMI Membership (TC 194 & TC 198)​
Strong presence at industry events​
ISO 13485 & ISO 19011 Certified Lead Auditor
FDA 21 CFR Part 820
MDSAP
EU MDR