Shazia A. Siddiqui has been in the industry for 20+ years with 10 years focused on medical devices (all classes) specifically in Wound Care, Cardiovascular, Ophthalmology and Dental areas.

Shazia joined NAMSA in 2010 where she has worked in various roles, including Principal Microbiologist. Shazia has continued to work with various groups at the site to develop, implement and improve processes and testing services that are critical to success. She continues to provide technical support to multiple teams across the site, as well as to R&D customers for new product development. Shazia also provides technical assistance to external and internal customers regarding microbiological inquiries. She possesses a comprehensive knowledge of antimicrobial standards, utilizing it to take the best course of action to ensure compliance with regulatory standards and testing requirements.

She has a Master’s degree in Genetics and a Bachelor’s degree in Microbiology. Shazia is a certified Microbiologist (National Registry of Certified Microbiologists (NRCM)) and acts as a subject matter expert in the custom microbiological lab at NAMSA. She is also an active member of the American Society for Testing Material (ASTM) and the American Association of Textiles Chemists and Colorists (AATCC).

CORE COMPETENCIES

• Comprehensive knowledge of antimicrobial standards and ensuring compliance with regulatory standards and testing requirements
• Extensive experience in antimicrobial efficacy tests
  • Writing protocols to accommodate specific requirements by modifying standards
• Designing validation studies for a wide range of wound dressing requiring 510K submission
  • Performing data analysis and writing custom reports
• Extensive knowledge of standards used in surface disinfectant studies
  • Writing validation protocols and final reports
  • Performing data analysis
• Registered Microbiologist (NRCM)

RECENT PROJECTS

• Designed validation studies for the efficacy of implantable devices coated with antimicrobial agents
• Designed an antimicrobial study to evaluate the potential activity of several lock solutions using catheters
• Wound Dressing – Developed validation studies for 510K submission
  • Provided insight on regulatory requirements and technical expertise to complete the project in record time
  • Client received FDA approval for their wound dressing

PUBLICATIONS

• “In Vitro Testing Strategies for Microbial Barrier Effectiveness,” White Paper authored by Shazia Siddiqui, MS, RM (NRCM), August 2022.

Conference Presentations

• “Role of Antimicrobial Textiles in Fight against Hospital Acquired Infections (HAI)”, Antibacterial and Odor Control: Marketing and Technology Advancement, Durham, NC, October 2019.