Medical Technology

You face complex and evolving regulatory environments which – while contributing to patient safety – still drive up compliance costs and delays product launches. On top of that, the rapid pace of technological advancement (think AI, IoT, etc.) means you must continuously innovate while maintaining compliance with those same regulatory standards – making obsolete traditional product development models.

Our approach, honed from decades working with MedTech companies, will change the way you work. With agilityIRL, you gain a partner born from the medical device industry that has “cracked the code” for accelerating product development and delivery. Our approach empowers you to:

• Streamline your Quality Management System (QMS), eliminating outdated practices while aligning with FDA guidance, saving you time and reducing compliance headaches.
• Build your Design History File incrementally, reducing last-minute stress and ensuring readiness at every development stage for faster, smoother releases.
• Enhance your team’s execution with specialized training and coaching, including exclusive Agile Regulatory training (CARS™ – Certified Agile Regulatory Specialist), ensuring your processes are as agile as they are compliant.
• Foster an organizational culture that supports seamless transformation, enabling your teams at all levels to operate with confidence, speed, and a sustainable path to innovation.

Transform your product development and see the benefits ripple through your entire enterprise