Sarah Frank

With over 5 years at the intersection of medical device testing and regulatory standards, Sarah transforms complex validation requirements into clear, actionable pathways for manufacturers. From Element’s Cincinnati laboratory, she delivers the specialized microbiology and reprocessing expertise needed to validate your medical devices efficiently and navigate regulatory submissions with confidence.

Experience

Sarah brings specialized expertise to the complex world of medical device validation. She helps manufacturers navigate tight timelines, shifting regulatory landscapes, and intricate testing requirements with practical, standards-based solutions.

Sarah excels at translating technical requirements into effective testing strategies for biocompatibility, sterilization validation, and reprocessing verification. Her hands-on experience with VHP sterilizers, probe reprocessors, endoscopes, and surgical instrumentation provides valuable insight into the specific challenges these products face during testing and validation.

Working from Element's Cincinnati laboratory facilities, Sarah provides the technical knowledge and standards expertise needed for accurate, compliant testing. Her methodical approach helps prevent costly delays and supports regulatory submissions with thorough documentation and reliable data interpretation.

Career Highlights

• Brings real-world standards expertise as an active member of multiple AAMI sterilization standards working groups
• Successfully orchestrated the complex transition of microbiological and cleanliness sting operations across multiple facilities—ensuring testing continuity for clients
• Developed custom validation protocols for challenging medical devices including VHP sterilizers, endoscopes, and reprocessors
• Delivers comprehensive guidance through the entire testing cycle—from protocol development to final validation reporting
• Consistently helps clients overcome technical obstacles that threatened submission timelines

Specialisms

• Medical device reprocessing validation
• Sterilization validation and efficacy testing
• Critical biocompatibility assessments
• Manufacturing cleanliness evaluation
• Antimicrobial performance testing
• Custom protocol development
• Regulatory submission documentation

 Professional Qualifications

• Bachelor of Science in Chemistry, University of Minnesota, Minor in Biochemistry

Affiliations / Memberships / Working Groups

• Active member of multiple AAMI working groups developing sterilization standards

Sector Expertise

• Medical Devices
• Reusable Medical Equipment
• Sterilization Technologies
• Microbiology Testing