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
San Luis Obispo, California, United States
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.
Medical Device Biological Evaluation Basics
An insightful training PDF designed for professionals in the medical device industry, offering a comprehensive and accessible guide to mastering the basics of biological evaluations, biocompatibility requirements, and regulatory considerations.
Medical Device Chemical Characterization Basics
A comprehensive training PDF tailored for professionals and researchers in the medical device industry, providing an in-depth exploration of foundational principles and methodologies for chemical characterization.
Biocompatibility Consulting
Evaluating products and material composition for compatibility with patients and users.
Biological Safety Evaluation Flow
A downloadable reference flowchart for biological safety evaluations.
Chemistry Consulting
Gaining an understanding of the chemical profile of your products and how that impacts patient and consumer safety.
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.
Medical Device Biological Evaluation Basics
An insightful training PDF designed for professionals in the medical device industry, offering a comprehensive and accessible guide to mastering the basics of biological evaluations, biocompatibility requirements, and regulatory considerations.
Medical Device Chemical Characterization Basics
A comprehensive training PDF tailored for professionals and researchers in the medical device industry, providing an in-depth exploration of foundational principles and methodologies for chemical characterization.
Biocompatibility Consulting
Evaluating products and material composition for compatibility with patients and users.
Biological Safety Evaluation Flow
A downloadable reference flowchart for biological safety evaluations.
Chemistry Consulting
Gaining an understanding of the chemical profile of your products and how that impacts patient and consumer safety.
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.
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
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)
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.
Overview of the certification process for DBS components.
Profile of James H. Borowick and his contributions.
Discussion on the impact of endocrine-disrupting chemicals.
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.
Overview of the certification process for DBS components.
Profile of James H. Borowick and his contributions.
Discussion on the impact of endocrine-disrupting chemicals.