Regulatory Affairs Training
Regulatory Affairs Training for Medical Devices in the U.S.
With complex FDA regulations evolving constantly, companies must ensure their teams are equipped to meet compliance expectations across the product lifecycle.
To effectively navigate the U.S. medical device market, your team needs more than just access to information—it needs structured, up-to-date training guided by regulatory experts. That’s where Sobel Consultancy comes in.
Our regulatory affairs training is designed to prepare your team to understand and apply FDA requirements with confidence, supporting your business in building solid regulatory foundations and reducing compliance-related risks. From core regulations like 21 CFR 820 to risk management aligned with ISO 14971, we deliver the knowledge your company needs to operate successfully in the U.S. market.
How we support your company with Regulatory Trainings
Our training program is structured to deliver both foundational knowledge and in-depth content tailored to the U.S. regulatory environment. Delivered online or on-site, the sessions combine technical content, real-world examples, and regulatory strategy for enhanced learning. Key topics include:
FDA regulations and submission types, including 510(k), PMA, De Novo, IDE, and HDE;
21 CFR 820 – Quality System Regulation (QSR) overview and practical applications;
ISO 14971-based risk management, covering hazard identification, risk evaluation, control measures, and benefit-risk analysis;
Regulatory strategy across the device lifecycle, including production and post-market monitoring;
Best practices for compliance with FDA expectations and avoiding common regulatory pitfalls.
Training sessions are led by regulatory experts and designed to be interactive, allowing participants to ask questions, analyze scenarios, and apply knowledge directly to their roles.
Why do you need this service?
Learn how to interpret and apply FDA requirements through structured, expert-led content.
Get hands-on insights into 21 CFR 820 and ISO 14971 principles relevant to manufacturing, quality, and safety.
Strengthen your team’s ability to detect and address non-conformance issues before they impact business outcomes.
Whether you’re looking to build regulatory capabilities internally or update your team on recent changes, this training adds real value to your operations.
With a focus on clarity, accuracy, and engagement, we make it easier to understand how to learn regulatory affairs and apply that knowledge in practice.
Our regulatory affairs training courses are tailored to meet organizational needs—whether you’re a startup navigating your first FDA submission or a global company enhancing internal processes.
Need Training in Regulatory Affairs for the U.S. Market?
Avoid costly delays and compliance gaps by investing in professional training aligned with FDA expectations. Our programs are available online or on-site, with flexible formats to accommodate your team’s schedule.
Contact us today to learn more about our regulatory training services for medical devices and how we can help your team strengthen compliance with confidence.
