Agile product development within FDA-regulated industries requires determination, industry knowledge and skill. Each step in the process must comply with FDA regulations as well as your own Quality Management System (QMS). To help you successfully employ Agile in this environment, we offer our Certified Agile Regulatory Specialist™ (CARS™) program.
What Is CARS™?
Our CARS™ program equips you with field-proven concepts, rules, methods and tools for incorporating Agile into an FDA-regulated and QMS-governed environment. The program has been designed and developed by agilityIRL and Agile Quality Systems, pioneers in Agile development and experts in medical device development.
During this two-day program, you’ll learn how to realize the benefits of Agile-driven development that also satisfies the reality of regulatory requirements. We’ll discuss a wide range of in-depth topics, including, but not limited to:
- An overview of medical device regulations and standards
- Tailoring your process and Agile practices to match the system or product you develop
- Aligning Agile with industry regulations and standards
- Roles and responsibilities for ensuring compliance with your process
At the end of the program, you’ll have the knowledge needed to take and pass a certification exam. Once complete, you’ll receive Certified Agile Regulatory Specialist™ status.
The Many Benefits of CARS™
CARS™ offers many benefits for those who take part in the program:
- Gain an in-depth understanding of regulations: You’ll have a better understanding of medical device regulations so you can challenge your assumptions of what regulators expect from your development process.
- Gather insights into your QMS: You’ll gain insights into your own Quality Management System to recognize where improvements are possible.
- Break down barriers: You’ll learn what regulations and standards actually require and where your company is creating barriers that aren’t mandated by the FDA.
- Become a leader: You’ll have the information and tools required to guide your organization in their adoption of Agile methods.
- Speed up your development process: You’ll make better products, faster using Agile methods.
Who Is CARS™ For?
Are you a change agent who wants to learn how to better communicate with the process people? Are you a manager or Scrum master working on a product and running into resistance?
CARS™ is a great fit for those who are currently employing or considering moving to an Agile development framework, including:
- Members of the Quality Assurance organization, including leadership
- Compliance personnel and internal auditors
- Leaders responsible for delivery of FDA-regulated products
- Program managers
- Development team leaders (definers, designers, testers)
Agility Is Possible in an FDA-Regulated & QMS-Governed Environment
Believe it or not, it isn’t the FDA rules that make Agile difficult for your company. It’s the Quality Management System that you implement which often doesn’t play well with Agile practices. And unfortunately, these processes often melt into the pot of regulatory need, when that just isn’t the case.
Our CARS™ program helps remove barriers, placing you in a better position to execute a fully compliant Agile system from the start.
Register for a CARS™ Certification Course Today
If you’re ready to better understand what it takes to develop products and services using Agile methods while remaining FDA-compliant, our CARS™ program is for you. Register for a CARS™ certification course today.