Biological Safety Consulting
Biocompatibility and Toxicology
- Experienced with a range of complex devices, including permanent implants, biodegradable and in situ curing devices, nanomaterials, animal tissues, novel materials (i.e., new to market), combination products, blood-contacting, neurological, respiratory/gas pathway and ophthalmic devices
- Medical device biocompatibility, including design of and guidance on biological, chemical characterization, Extractables/Leachables (E&L), and degradation testing (ISO 10993 series, ISO 18562, ASTM, USP, U.S. FDA Guidance, etc.)
- Draft and peer review of Biological Risk Assessments, Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) per ISO 10993-1 and EU MDR
- Toxicological Risk Assessments (TRA) per ISO 10993-17, ISO/TS 21726
- Equivalency assessments
- Test plans and premarket submission strategy
- Justifications/rationales
- Gap and change assessments
- Resolution of regulatory agency deficiencies
- Mitigation of test failures and unexpected test results (root cause analysis, investigation, re-test, justifications, evaluation of test lab procedures, other risk mitigations)
- Consultation on specific device or material questions
- Coatings and particulate analysis
- Biocompatibility of reusable devices and end of life cycle evaluations (i.e., impact of reprocessing and shelf life)
- Serve as subject matter experts (SME) for regulatory agency and test laboratory meetings, communications, and negotiations
- Biological safety training
Microbiology, Sterilization and Reprocessing
- Reprocessing (cleaning/disinfection/sterilization) of reusable and reprocessed single-use medical devices
- Manual and automatic cleaning validations
- Low-, intermediate-, and high-level disinfection validations
- Sterilization validations (steam, gamma, e-beam, ethylene oxide, hydrogen peroxide)
- EO residuals testing
- Novel disinfection and sterilization techniques
- Microbial ingress testing
- Antimicrobial effectiveness testing or other antimicrobial aspects for combination products
- Toxic Shock Syndrome Toxin testing
- Biofilm risks and testing
- Risk assessments
- Test plans and premarket submission strategy
- Justifications/rationales
- Gap and change assessments
- Resolution of regulatory agency deficiencies
- Mitigation of test failures and unexpected test results (root cause analysis, investigation, re-test, justifications, evaluation of test lab procedures, other risk mitigations)
- IFU development
- Product adoptions and equivalency assessments
- Product release testing
- Sterility, and bacteriostasis and fungistasis (B/F) testing
- Bioburden testing
- Bioburden and quarterly dose audits
- Environmental monitoring
- Microbial identification testing
- Endotoxin/LAL and pyrogenicity testing
- ISO certified clean room validations
- Laboratory equipment validations (IQ, OQ, PQ)
- Serve as subject matter experts (SME) for regulatory agency and test laboratory meetings, communications, and negotiations
Packaging and Shelf Life
- Packaging guidance and design
- Container closure systems for drug/device combination products, moisture-sensitive products, sterile barrier systems, cold chain logistics, flexible and rigid materials
- Forming/sealing process development and validation
- Aging and shelf life/stability studies (accelerating and real-time aging)
- Simulation shipping and handling (distribution) testing
- Packaging integrity/performance testing (barrier properties, burst testing, dye penetration, leak testing, peel strength, visual inspection, labeling legibility/adhesion, etc.)
- Usability
- Sterilization compatibility
- Product performance after shelf life
- Packaging biocompatibility
- Sourcing challenges and material replacements
- Remediation
- Risk assessments
- Gap and change assessments
- Test plans/protocols/reports
- Justifications/rationales
- Training and education
- Serve as subject matter experts (SME) for regulatory agency and test laboratory meetings, communications, and negotiations