At agilityIRL, we have distinctive experience in the life science industry. With this experience, we understand the critical nuances of operating an Agile framework (e.g., Scrum, SAFe, etc.) in an environment regulated by the Food and Drug Administration (FDA) and governed by a company’s own Quality Management System (QMS). For those working to become agile in this industry, our CARS™ program is a great fit.
Our exclusive Certified Agile Regulatory Specialist™ (CARS™) program is for those employing Agile in an FDA-regulated and QMS-governed environment. It has been designed and developed—and is presented—in collaboration with agilityIRL and Agile Quality Systems, pioneers in Agile development.
Like all agilityIRL products and services, CARS™ is agile-driven but reality-based. Its design and development flow from our decades of personal experience with Agile in medical device product development and participation on the team that authored AAMI TIR45: 2012. CARS™ has been created by a team that includes individuals that literally wrote the book on using Agile in medical device product development.
If you’re involved in any FDA-regulated or QMS-governed environment and wish to become Agile, our CARS™ certification is a great choice for you. To learn more about our programs, coaching or consulting, send us a message today.