Keep your team aligned with FDA requirements and ISO 14971 risk-management 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 and ISO 14971 requirements.
Effective risk management depends on professionals who understand how to identify hazards, evaluate risks, and document decisions correctly.
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 14971 risk management, 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.
RDC 848/2024 replaces RDC 546/2021 and introduces updated safety and performance requirements for medical devices, IVDs, and software. This training explains the regulation’s impact on manufacturers and importers, covering the fundamental requirements that must be met for market access in Brazil.
The European Medical Device Regulation (MDR 2017/745) represents one of the most comprehensive and complex frameworks worldwide. This training provides an overview of the MDR requirements, including classification, conformity assessment routes, technical documentation, and post-market surveillance obligations, helping companies prepare for EU compliance.
ISO 10993 is the international standard for biological evaluation, establishing how to assess biocompatibility and safety of medical devices. This training ensures that your team understands the latest updates to the standard, how to design biological evaluation plans, and how to avoid costly delays in regulatory submissions.
If you’re unsure which certification applies, Sobel provides initial guidance to map the right route and ensure full compliance.
With the right certification strategy, you gain a faster, safer, and compliant entry into the Brazilian market. Complement your certification process with:
We act as your official representative, managing vigilance and ongoing regulatory support.
Notification, registration, and updates under RDC 978/2025 and RDC 658/2022.
Reliable, cost-effective biological evaluation documents aligned with ISO 10993 and Anvisa requirements.
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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