Certified Agile Regulatory Specialist (CARS™)

What is CARS™?

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.

CARS™ is Agile-Driven But Reality Based

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 2-Day Program

Our CARS™ program is a 2-day class that teaches you field-proven concepts, rules, methods and tools for incorporating Agile in an FDA regulated and QMS governed environment. Following the program, candidates with qualifying class attendance and participation, as determined by the instructor, will be eligible to take an exam to earn their CARS™ certification.

To view a copy of the course outline, you can download it here.