Jodi Scott developed and honed her practical, real-world sensibility and business acumen during the time she spent as an in-house FDA counsel with Medtronic PLC, the world’s largest medical device manufacturer. Today, she uses that background to solve the challenges that confront her clients in areas that include MDRs, regulatory due diligence, importing and exporting medical devices, advertising and promotion, preparing for and managing FDA inspections, developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses), developing digital health technology, and securing the necessary state medical device manufacturer and distributor licenses. Scott assists the medical device industry in navigating complex requirements to maintain compliance with the U.S. Food and Drug Administration’s (FDA) quality system (QSR) and other post-market regulatory rules. She spends much of her time developing and implementing strategies to manage FDA-initiated enforcement actions, such as FDA inspections that result in FDA Form 483s, untitled letters, Warning Letters, investigations, and consent degrees of permanent injunction. She has received ISO 13485 auditor certification and assists companies in preparing for managing and responding to ISO and MDSAP audits.