Knowledge
is
empowerment

Bringing you expert guidance and practical solutions for global medical device compliance

Commited to helping medical device innovators navigate complex regulatory landscapes.

Learn the steps.

At Practical RA, we believe that every company, regardless of size, deserves the opportunity to bring safe, compliant medical devices to market. Our mission is to simplify the complex world of regulatory affairs and provide accessible, practical solutions to small and medium-sized businesses.

Lead the way.

From comprehensive training courses to practical, easy-to-use tools, our solutions are crafted to guide you through every step of the regulatory process. Whether you’re looking to get your first product approved or streamline your compliance processes, our offerings are designed with your success in mind.

Our Story

Practical RA was formed in late 2019 by a pair of regulatory affairs consultants. Our first offering was a training course focused specifically on the then-impending transition to the EU Medical Device Regulation (MDR 2017/745). Our priority was informative yet practical content, focusing on application rather than theory alone.

The course was a hit, reaching best-selling status on the Udemy course platform with thousands of learners all over the world. We soon expanded our team and course offerings to tackle topics we most often saw medical device manufacturers struggle with.

In 2024, we partnered with UK-based developers to create SAGE AI; our EU MDR Submission Builder, intended to empower non-regulatory folk to develop a compliant and robust EU medical device submission, through a step-by-step compilation process.

We have many more projects and tools in the pipeline which we can’t wait to share with you, and we are always eager to hear how we can improve our offerings.