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- Toxicologists in Biocompatibility, Chemical Characterization, Risk Assessment, Good Laboratory Practices and Data Integrity of Medical Device Research, Development, Premarket, Postmarket
- Szot, Robert. J.
- Gad, Shayne C.
- Kaminsky, Marvin
- Kuna, Robert A.
- Northup, Sharon J.
- Rice, Susan A.
- Rodgers, Kathleen
- Schuh, JoAnn C.L.
Some Functions of Medical Device Toxicologists:
Product Development
Selection of Biocompatible Materials
Initial Toxicology and Chemistry
Standard Operating Procedures for Material Evaluation
Tests for Regulatory Submission
Justifications for Tests not Performed
Laboratory Selection
Laboratory Request for Proposals (Rfp)
Test Protocols
Laboratory Monitoring - Phases of Clinical / Non-Clinical Study
Review Preclinical and Nonclinical Study Data
Methodology and Conclusion Evaluation
Summary Toxicology and Biocompatibility Evaluation for Regulatory Submission
Interaction with Regulatory Authorities
Potential Risk of Toxicity
Potential Impact on Safety of Changes to Device Materials or Processing
Troubleshooting
Potential Risk of Toxicity
Acquisitions
Evaluation of Integrity of Safety Data submitted
Due Diligence