Our Work
Cook Medical
Directed a global legacy product remediation program to achieve EUMDR compliance.
Established risk-based prioritization, linked failure modes to known harm, and aligned product/process documentation with Quality Management System standards. Delivered 9 certified conformity files, 23 regulatory handovers, 20 marketing authorization packages, and implemented processes that positioned the organization for ongoing compliance improvements and operational efficiency.
"Testimonial"
DxI 9000 Immunoassay Analyzer
Managed a decade-long, $3B global new product development program spanning multiple countries.
Implemented governance structures and coordination practices that enabled consistent execution across this highly complex initiative.
"Testimonial"
Cantel Medical (Now Steris)
Led the design and delivery of a custom automated manufacturing facility for a $1B global medical device company, a 40,000-square-foot operation with Class 8 cleanroom.
Managed full regulatory, quality, and safety compliance while sourcing equipment, optimizing processes, and leading cross-functional teams. Reduced scrap rates from 20% to 2%.
"Testimonial"
3M
"Testimonial"case study…
Abbott
case study…
"Testimonial"