After more than 20 years in medical device industry (manufacturing, quality and regulatory), I have started my new nexialist challenge in February 2022 as Quality Consultant with one main focus “THE PATIENT”, thus product safety.
I worked for medical device supplier (plasma spraying and EO sterilization) & for orthopedic manufacturers. These experiences allowed me to build an international quality expertise (ISO 13485, 21 CFR part 820, Canada, Brazil, Australia for example) including Competent Authority Inspections management (FDA, ANVISA, ANSM …) and also expertise in Change Control, Process Validation, Regulatory Affairs and as Quality Representative for Design and Regulatory submission.