Certified Agile Regulatory Specialist™ (CARS™) Education, Certification and Coaching

A Program for those Employing Agile
In an FDA Regulated Environment

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.

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** Exam only available after CARS™ course completion **

Achieve CARS™ Certification Through 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.

Pricing & Booking

CARS™ education and certification is offered in both public and private settings. Our schedule of public CARS™ classes is shown below:

To learn more about pricing and scheduling for a private CARS™ session, contact us.

Make the Transition: CARS™ Coaching & Consulting

In addition to our education and certification program, we offer coaching and consulting services to help you successfully make the transition from concept to application. Using our agile-driven and reality-based expertise, our CARS™ consulting is provided by consultants with FDA and QMS experience.

Pricing & Booking

Our CARS™ coaching is provided on a time-and-materials basis and varies depending on need. To discuss your needs and find a coaching solution that fits, contact us.

Learn More About CARS™ Education & Consulting Today

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.