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

biotechnology
medical-device
pharmaceutical

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.


Services

Free 30-minute introductory call to discuss project scope, regulatory needs, and next steps.

Short technical seminars covering topics such as biocompatibility, sterilization, and microbiology for internal teams.

Project management and coordination of sample testing with accredited third-party laboratories to meet ISO and FDA requirements.

Curated webinar content and virtual training modules on topics including EU MDR implementation, biocompatibility, sterilization, and diagnostics.

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
  • Show More (6)

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)
  • Show More (10)

News & Updates

Join Peter Holper from SCIEX to discover a new approach to finding a robust, sensitive sizing method for residual nucleic acid analysis.

Discussion of applications ranging from syringes and needles to PPE, catheters, and more.

Exploration of NLoS imaging technology and its impact.

Profile of James H. Borowick and his contributions.

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