Keep your team aligned with FDA requirements and ISO 10993-1 principles through structured, expert-led training. Our Regulatory Affairs training give your organization the clarity and confidence needed to operate compliantly in the U.S. market.
Build stronger regulatory foundations with expert guidance.
Regulatory expectations are increasing, and your team needs consistent, accurate guidance to interpret FDA and ISO 10993-1 requirements.
A solid understanding of ISO 10993-1 is key to conducting biological evaluations that meet regulatory expectations and support product safety.
Well-trained teams prevent nonconformities, reduce delays, and strengthen compliance across every stage of your device lifecycle.
Our training programs are designed for practical application — presented through real-world examples, clear explanations, and interactive discussions.
Delivered online or on-site, each session equips participants to apply regulatory concepts directly to their daily activities, improving compliance and product outcomes.
With expert-led sessions delivered online or on-site, Sobel Consultancy provides a clear pathway to understanding FDA expectations, mastering ISO 10993-1, and strengthening internal processes that support safe, compliant products.
A comprehensive training focused on FDA’s 21 CFR 820 requirements, including quality management expectations, inspection readiness, and practical compliance applications. This 6-hour training equips teams to understand QSR structure, responsibilities, documentation needs, and how FDA assesses quality systems.
ISO 10993 sets the framework for biological evaluation and biocompatibility assessment of medical devices. This training helps teams stay aligned with current requirements, structure biological evaluation plans, and address common issues that may impact regulatory timelines.
Investing in professional, structured training is one of the most effective ways to build internal regulatory capabilities, prevent nonconformities, and accelerate successful product development.
With Sobel, your team gains clarity, confidence, and a solid understanding of FDA and ISO 10993-1 requirements — ensuring safer devices and stronger compliance outcomes.
1. Who should attend these training programs?
These trainings are ideal for regulatory affairs teams, quality professionals, R&D engineers, manufacturing specialists, and anyone involved in risk management, documentation, or FDA submissions.
2. Do the trainings cover practical applications or only theory?
The sessions combine both. Participants receive structured technical content supported by real-world examples, scenario discussions, and practical explanations to apply the requirements in daily work.
3. Why is 21 CFR 820 training important for our organization?
Training on 21 CFR 820 prepares your team to meet FDA quality-system expectations, understand documentation requirements, and avoid common compliance issues. It helps establish a strong QMS foundation and improves readiness for inspections and U.S. market entry.
4. Can the training be delivered online?
Yes. All programs can be delivered remotely via Microsoft Teams or on-site at your facility, depending on your preference and schedule. Each attendee receives an official certificate of completion at the end of the training.
5. Can the content be customized to our company or device type?
Yes. While the core modules follow FDA and ISO requirements, examples and discussions can be adapted to your company’s regulatory context and device category.
6. How do we schedule the training?
Once you contact our team, we align the training scope, select the format (online or on-site), define participants, and set the date that best fits your team’s availability.
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