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...Read More
“How do we report status?” “How do I get insight into the product?” These are frequent questions we receive from our clients as they move to an Agile method like Scrum. The short answer to both of these questions is: eliminate status reports and attend the Sprint Review. After all, as the aphorism states, “there’s...Read More
