Team

Curtis Wichern

Consultant, Medical Device Software

Curtis is a highly motivated software leader with over twenty-five years of experience in software development with fifteen of those years in medical devices as a design and quality leader. He has built several successful technical teams to solve difficult problems. He uses his knowledge of industry best practices to strategically apply design controls, development methodologies, and regulatory standards to Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products. He knows a variety of programming languages, frameworks, and databases.

Academic & Professional Qualifications:
  • Bachelor’s of Science, Information Technology, Brigham Young University
  • Risk Management Specialized Credential, American Society for Quality
Training, Quality Systems, and Specialties:
  • FDA Quality System Regulations / GMP / SaMD
  • EU Medical Device Regulation (MDR)
  • ISO 13485 Medical Device Quality System Management Systems
  • IEC 62304 Medical Device Software Life-cycle Processes
  • IEC 82304 Health Software, General Requirements for Product Safety
  • ISO 14971 Risk Management