Mercedes Figa, Principal Microbiologist, is an analytical scientist with more than 10 years experience in various aspects of medical device analysis.
Mercedes is Element's Principal Microbiologist leading medical device testing. Utilizing Element's state-of-the-art cleanroom laboratories, Mercedes oversees studies including Bioburden, Bacterial Endotoxin (LAL) and Cytotoxicity. She is also highly skilled in IQ/OQ/PQ, method development and analysis.
Mercedes' expertise also expands to pharmaceuticals and water utilizing USP 61/62 Microbial Testing and USP Water Analysis (Microbial, Endotoxin, TOC, Conductivity).
- 10+ years with a major orthopedic manufacturer
- 15+ years in laboratory research and testing
- Knowledge of compliance requirements and regulatory environments
- Experience in operating in accordance with GLP and GMP reuirements
- Operational knowledge of analytical instrumentation and material/tissue sample handling and analysis
- Biologic and Synthetic Material Sample Analysis
- Histological and Immunological Tissue Analysis
- Microscopy and Digital Image Analysis
- Thermal Analysis - DSC, MDSC, TGA, DMA
- Chromatography - GPC, GC, GC/MS
- FTIR - Microscope, ATR, and Bench
- Polymer Research and Development
- Material Characterization
- Tissue Analysis and Characterization
- Medical Device Cleanliness
- Analytical Method and Instrument Validation
- Active Member of ASTM subcommittees for Device Cleanliness and UHMWPE