High quality, customized regulatory solutions for medical device and pharmaceutical companies

Regulatory Services

• International medical device regulatory requirements
  
• Regulatory strategy
  
• Regulatory assessments
  
• Resolution of regulatory agency deficiencies and non-conformities
  
• Regulatory agency meetings and negotiations
  
• Dossiers, technical documentation and technical files
  
• Technical/medical writing, including Clinical Evaluation Plans and Clinical Evaluation Reports
  
• Marketing and labeling compliance, including claims review
  
• Verification and validation testing requirements
  
• Customized training and education
  

U.S. FDA Premarket Submissions

• 510(k)
• De Novo
• Investigational Device Exemptions (IDE)
  
• Premarket Approvals (PMA)
  
• Pre-Submissions (Q-Sub)
  
• 513(g)
  
• Request for Designations (RFDs) and Pre-RFDs for combination products
  
• Humanitarian Use Device (HUD) Designations and Humanitarian Device Exemptions (HDE)
  
• Breakthrough Device Designations
  

Biological Safety Consulting

• Medical device biocompatibility
  
• Reprocessing (cleaning/disinfection/sterilization) of reusable and reprocessed single-use medical devices
  
• Microbial ingress testing
  
• Antimicrobial effectiveness testing or other antimicrobial aspects for combination products
  
• Biological Risk Assessments and Biological Evaluation Plans/Reports
  
• Biocompatibility and reprocessing testing plans and premarket submission strategy
  
• Gap assessments
  
• Resolution of regulatory agency deficiencies
  
• Mitigation of unexpected test results
  
• Consultation on specific device or material questions
  
• Coordination with third-party test laboratories
  
• Experienced with a range of complex products, including permanent implants, biodegradable and in situ curing devices, nanomaterials, animal tissues, novel materials (i.e., new to market), combination products, blood-contacting and neurological devices, novel disinfection and sterilization techniques
  

Dr. Katzenmeyer-Pleuss is a former U.S. FDA medical device reviewer with over 10 years of experience in the regulated medical device industry and over 20 years in the broader biomaterials field. She has extensive expertise in international medical device regulatory requirements and device biocompatibility and reprocessing (cleaning, disinfection, sterilization). Dr. Katzenmeyer-Pleuss holds a PhD in Bioengineering from the University of Washington and a Bachelor of Science in Chemical Engineering from the University of Wisconsin-Madison.

Prior to starting KP Medical Device Consulting LLC, Dr. Katzenmeyer-Pleuss worked as a Senior Regulatory and Biological Safety Consultant at NAMSA, a leading global Contract Research Organization (CRO), in both the United States and Europe. At NAMSA, she led and drafted regulatory submissions, led meetings with FDA, and developed regulatory assessments and strategy for international markets. She also served as a biological safety expert, drafting numerous Biological Risk Assessments/Biological Evaluations, advising on biocompatibility testing plans, and supporting clients through various complex situations with regulatory agencies, unexpected test results, and new materials.

While at U.S. FDA, Dr. Katzenmeyer-Pleuss worked as both a lead and senior reviewer for pre-market medical device submissions as well as a subject matter expert in biocompatibility, sterilization, and reprocessing (reusable and reprocessed single-use devices). She was actively involved in medical device policy development, drafting Guidance documents, and served on several standards committees as well as internal working groups related to Early Feasibility Studies (EFS), antimicrobials, reprocessing, biocompatibility, and new reviewer practices. During her U.S. FDA tenure, Dr. Katzenmeyer-Pleuss also served as a technical expert at manufacturing site inspections and provided consults to FDA’s Office of Compliance to support compliance actions (e.g., issuance of Warning Letters).

In her role as President of KP Medical Device Consulting LLC, Dr. Katzenmeyer-Pleuss works collaboratively with clients ranging from small start-ups to large multinational medical device and pharmaceutical companies. She often serves as a subject matter expert for medical device submissions, strategizing plans for regulatory agencies clearances/approvals and addressing deficiencies in an efficient manner, and assisting in the development of complex or custom testing with third-party laboratories. Dr. Katzenmeyer-Pleuss is especially adept at navigating intertwined regulatory and biological safety requirements while keeping in mind each client’s unique business needs.