Team

Mickey Burg

Associate Director, Program Management

Mickey joined Suttons Creek with over 15 years of medical device experience ranging from design and development of In Vitro Diagnostic Assays through the creation of Program Management Teams responsible for Reagents, Assays, Software, Instruments, and Companion Diagnostics. She brings a love of problem-solving and a talent for organization and resource management to maximize the effectiveness of project execution. With her start in Research and Development and experience in highly regulated environments, she functions at the intersection of creative solutions and risk mitigation in her approach to managing and improving medical device and combination product programs.

Academic & Professional Qualifications:
  • MS in Applied Molecular Biology – University of Wisconsin-Parkside
  • BS in Molecular Biology and Bioinformatics – University of Wisconsin-Parkside
  • PPI 8 Step Process Manager
Training, Quality Systems, & Specialties:
  • EN ISO 13485 & ISO 13485 Medical Devices Quality Management Systems
  • In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC
  • In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746
  • Canadian Medical Devices Regulations (CMDR) – Part 1 – SOR 98/282
  • FDA, 21 CFR Part 820 for Medical Devices; Quality System Regulations
  • ISO 14971 Medical Devices – Risk Management – Application of Risk Analysis to Medical Device
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