Megan A. Hahn, PhD, DABT

Dr. Megan Hahn is an experienced Toxicologist with a demonstrated history of working in the medical device industry, successfully working within multidisciplinary teams. Prior to joining NAMSA in 2019, she spent 6 years at Medtronic where she was a Senior Toxicologist, evaluating biocompatibility, performing toxicological risk assessments and supporting regulatory submissions for various types of medical devices used in otolaryngological and neurosurgical applications.

Dr. Hahn received her PhD in Chemistry at the University of Rochester (Rochester, NY), developing semiconductor quantum dots for labeling pathogenic bacteria. In 2022, she received her Diplomate of the American Board of Toxicology (DABT) certification. She is an active member of the Medical Device and Combination Product Specialty Section (MDCPSS) of the Society of Toxicology (SOT), where she has served on the Executive Committee in various roles. She is also a member of the American Chemical Society (ACS).

CORE COMPETENCIES 

• Preparing biological and toxicological risk assessments, gap analyses, literature reviews, evaluation plans and reports in compliance with ISO 10993-1, ISO 10993-17 and ISO 14971, for submissions to the U.S. Food and Drug Administration (FDA) and other regulatory agencies and Notified Bodies
• Evaluating and summarizing biocompatibility and general toxicology data to ensure compliance with relevant regulatory requirements and standards
• Working knowledge of FDA, EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR) and other global medical device regulations and/or biologics regulations, ISO 10993 series and ISO 14971
• Ensuring compliance for biocompatibility studies with the most recent regulatory requirements
• Developing proposals for biocompatibility for submission to multiple regulatory bodies
• Providing technical support to laboratory staff
• Advising clients on technical issues related to biocompatibility and material characterization
• Performing biocompatibility gap analyses and writing clear concise reports
• Performing and summarizing literature searches
• Evaluating and determining biological relevance of unexpected results
• Directing non-standard analytical chemistry studies to determine extractables/leachables from medical devices 
• Performing in silico/read across for medical device extractables/leachables without toxicological data

RECENT PROJECTS 

• Worked diligently with a client for over a year to develop their biocompatibility test plan, addressed unexpected test results and communicated with the FDA during their interactive review, which led to successful IDE approval for their complete orthopedic system (consisting of multiple implants, instruments, and accessories)
• Evaluated and documented biocompatibility of a client’s entire product portfolio, which contained hundreds of devices, to comply with EU MDR requirements

• Provided scientific support for a client during communication with the FDA, which successfully led to market clearance for their device in the United States without the need for additional testing

• Assessed extensive extractables and leachables chemical characterization data sets using Quantitative Structure-Activity Relationship (QSAR)/read-across approaches and performed the subsequent toxicological risk assessments for a variety of long-term medical devices