Employing Agile in an FDA Regulated Environment

Anasthesia MachineIntroducing CARS – A Certified Agile Regulatory Specialist Program

Is yours is an environment regulated by the Food and Drug Administration (FDA), and thus also a corporate Quality Management System (QMS)?

Are you considering, or already employing one of the Agile frameworks (e.g., Scrum, SAFe, etc.)?

Do you know how to adapt your Agile framework to work with your corporate QMS and the myriad of FDA regulations, standards and guidance?

agilityIRL, in collaboration with Agile Quality Systems, is developing a certification program that will teach field-proven practices (e.g., concepts, rules, recommendations, methods, tools, etc.) for incorporating Agile in an FDA regulated and QMS governed environment.

We are calling our program the “Certified Agile Regulatory Specialist,” or CARS.  CARS is Agile agnostic, and will consist of a 2-day class and certification exam, with successful candidates earning their CARS certification.

CARS is currently in development, and we are hoping to launch it in Spring 2019.   Learn more and sign up to receive email updates as we bring CARS to market.