Art and Sciences of Chemical Characterization of Extractables and Leachables of Medical Devices
- Thursday
- February
- 12
- 2026
Dr. Mourad Rahi Overview:
The topic highlights results deemed inaccurate from review of numerous analytical reports for chemical characterization of medical device extracts submitted for toxicological risk assessment
Why you should Attend:
Key takeaways: Arts and Sciences of analytical data interpretation and corroboration to distinguish between accurate and inaccurate analytical data
- How to distinguish between accurate and inaccurate analytical data submitted for Toxicological Risk Assessment (TRA)
- Learn strategies to overcome common analytical challenges in E&L study design, data interpretation, and corroboration
- Understand the ambiguities and limitations of current guidelines and their impact on toxicological risk assessment and device safety
- Gain insight into the ongoing AET and LOD calculation controversy for long-term implants
- Learn how to be a voice for fundamental change of guidelines
- Five years of analytical data from various laboratories and results of independent projects since 10993-18 (2020) should be the driving force for fundamental change of the guidelines and industry practice
Areas Covered in the Session:
Provide actual examples from various analytical reports of the process failure in data acquisition, interpretation and reporting for toxicological risk assessment
- Inaccurate identification of hundreds of unexpected extractable organic compounds from metal or simple alloy implants
- Identification of compounds in solvent extracts that do not follow the principle of solubility or stability
- Identification of compounds that do not follow the principles of chromatography and spectroscopy
- Identification of compounds that do not comply with the mass spectra fragmentation pattern
- Identification of several non-isomeric compounds eluting at different retention times in same chromatographic profile
- Identification of different compounds following concentration of solvent extracts as compared to compounds identified before concentration
- Inaccurate Identification of compounds based on library search and use of extracted ions
- Identification of multiple compounds in chromatographic profile of device extracts indistinguishable from chromatographic profile of control extracts
- Pressure for reporting compound identification as marketing tools: “No compound left unidentified”
- Designation of un-experienced project managers/monitors in analytical chemistry
- Lack of proper training of chemists leads to widespread reporting of inaccurate analytical data
- Analytical data submitted for TRA speaks volume about the process as follows
- Guideline requires fundamental revision as will be highlighted in the next session
Who Will Benefit:
- Medical Device Manufacturers
- Pharmaceutical Companies
- Suppliers of raw Materials for Drug Synthesis and Construction of Medical Devices
- Toxicologists Involved in Risk Assessment,
- Engineers involved in R&D
- Testing Laboratories and CROs
- Consulting firms for Study Design and Regulatory Requirements
- Quality Assurance
- FDA
- Regulatory Agencies
- Analytical Instrument Manufacturers and Suppliers
Speaker Profile
Dr. Mourad Rahi earned his Ph.D. in Chemistry from the University of Cincinnati and brings over 35 years of experience in academia, CROs, and the medical device and pharmaceutical industries. A recognized authority in the chemical characterization of extractables and leachables (E&L), he is a frequent speaker at international conferences, advancing best practices in study design, analytical data acquisition, and toxicological risk assessment.
Dr. Rahi has extensive expertise in ISO 10993-1 compliance and has established analytical laboratories supporting E&L and pre-clinical studies for pharmaceuticals and medical devices under GLP and ISO 17025 standards. His background in organic synthesis, chromatography, spectroscopy, and structure elucidation equips him to design robust studies, particularly for complex medical devices where extract-induced reactions and detection limits can pose significant analytical challenges.
He holds multiple patents in medical device design and drug formulations using NanoElectroSpray technology, and has authored peer-reviewed publications in analytical sciences and regulatory compliance. Dr. Rahi continues to play a leading role in shaping global standards for chemical characterization and toxicological evaluation of medical devices.