Your basket is currently empty!
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
At Practical RA, we’re a small team of regulatory affairs professionals with a shared mission: to empower innovators in the medical device space.
Founded in 2020, Practical RA was born out of years of hands-on experience helping companies, from lean startups to Fortune 500 leaders, navigate the complex world of global medical device regulations. We’ve worked across North America, Europe, Australasia, and beyond, guiding organisations through compliance challenges and regulatory submissions with clarity and confidence.
Who We Are
We’re not a big consultancy or a faceless course provider. We’re practitioners: QA/RA experts who’ve sat on both sides of the table. We’ve authored submissions, built quality systems from scratch, and advised on MDR, IVDR, FDA 510(k), ISO 13485, and more. Now, we bring that experience directly to you.
Our team creates practical, high-impact tools, courses, and resources designed specifically for small businesses and emerging medtech companies. Whether you’re launching your first product or scaling a global portfolio, we’re here to help you get to market faster without compromising on compliance.
Our Impact
Since launching, we’ve helped nearly 5,000 students and professionals strengthen their regulatory knowledge through our training and tools. We’re proud to support a growing global community of medical device innovators who are shaping the future of healthcare.
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.
Ready to take control of your regulatory strategy? Explore our services or contact us for personalized support tailored to your business needs.