Team
Kelly Wedig
Principal Consultant
Kelly Wedig is a medical device engineer with 10+ 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:
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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