Team

Michelle has over 13 years of experience in the medical device and pharmaceutical industries, with expertise in quality systems, risk management, and combination product development. As a lead on auto-injector development and lifecycle programs, she planned formative and summative human factors studies and drove risk management and design control remediation. She has supported global medical device manufacturers with post-market surveillance, quality system integration, and EU MDR technical documentation. She has also built successful quality management systems for startup-phase novel devices and led them through audits and inspections. Michelle enjoys working with the Regulatory & Quality community, most recently as a committee member of the inaugural RAPS Quality Conference.