Team

Kelly Wedig

Senior Consultant

Kelly Wedig is a medical device engineer with 9+ years of experience in combination product research and development, post-market surveillance, and lifecycle management. Over her career, she has supported the development and management of various types of combination products including on-body injectors, prefilled syringes, auto-injectors, and nasal spray systems. She is enthusiastic about improving the lives of patients by delivering state-of-the-art medical products through innovation, collaboration, and quality. Kelly has a proven track record of being a reliable asset with excellent problem-solving skills, all of which lead to delivering results in a fast-paced, competitive, and highly regulated medical device industry.

Academic & Professional Qualifications:

  • B.S. Biomedical Engineering, University of Wisconsin – Madison

Training, Quality Systems, & Specialties:
  • Combination Product Development
  • Design Controls
  • Risk Management
  • Root Cause Analysis
  • Post Market Surveillance & Lifecycle Management
  • Complaints Handling
  • Engineering Statistics
  • Human Factors Engineering
  • 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • ISO 11608
  • IEC 60601-1
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