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

Profile 

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). 

Industry Experience
  • 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
Project Experience 
  • 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  
Conferences 
  • Active Member of ASTM subcommittees for Device Cleanliness and UHMWPE
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