Mercedes Figa, has more than 10 years experience in various aspects of medical device testing and 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