MicroBio Consulting
MicroBio Consulting is committed to advancing science, supporting scientists, and developing medical technology through expert consulting services in microbiology, sterilization, reprocessing, biocompatibility, chemistry, toxicology, forensic science, and more. They provide validation, testing coordination, and regulatory guidance to ensure safety and efficacy of medical devices, pharmaceuticals, and other products.
Industries
Nr. of Employees
small (1-50)
MicroBio Consulting
Chisago City, Minnesota, United States, North America
Products
On‑demand webinar library
Collection of curated on‑demand webinars covering technical topics such as extractables/leachables, sterilization, EU MDR, spatial genomics, and diagnostic testing.
On‑demand webinar library
Collection of curated on‑demand webinars covering technical topics such as extractables/leachables, sterilization, EU MDR, spatial genomics, and diagnostic testing.
Services
Introductory consulting call
Free 30-minute introductory call to discuss project scope, regulatory needs, and next steps.
Lunch and Learn sessions
Short technical seminars covering topics such as biocompatibility, sterilization, and microbiology for internal teams.
Testing coordination and third‑party lab management
Project management and coordination of sample testing with accredited third-party laboratories to meet ISO and FDA requirements.
Virtual trainings and on‑demand webinars
Curated webinar content and virtual training modules on topics including EU MDR implementation, biocompatibility, sterilization, and diagnostics.
Regulatory and standards advisory
Interpretation and application of relevant FDA and ISO standards (e.g., ISO 10993 family, ISO 18562, ISO 17025, ISO 14644) to product development and submission planning.
Introductory consulting call
Free 30-minute introductory call to discuss project scope, regulatory needs, and next steps.
Lunch and Learn sessions
Short technical seminars covering topics such as biocompatibility, sterilization, and microbiology for internal teams.
Testing coordination and third‑party lab management
Project management and coordination of sample testing with accredited third-party laboratories to meet ISO and FDA requirements.
Virtual trainings and on‑demand webinars
Curated webinar content and virtual training modules on topics including EU MDR implementation, biocompatibility, sterilization, and diagnostics.
Regulatory and standards advisory
Interpretation and application of relevant FDA and ISO standards (e.g., ISO 10993 family, ISO 18562, ISO 17025, ISO 14644) to product development and submission planning.
Expertise Areas
- Biocompatibility testing and ISO 10993 compliance
- Sterilization and sterilant residuals evaluation
- Microbiology and sterility testing
- Toxicology and risk assessment
Key Technologies
- High-performance liquid chromatography (HPLC)
- Gas chromatography–mass spectrometry (GC–MS)
- Liquid chromatography–mass spectrometry (LC–MS)
- Inductively coupled plasma mass spectrometry (ICP‑MS)