Regulatory compliance is one of the greatest challenges for medical device manufacturers and importers. From ISO 13485 and MDSAP to Anvisa’s RDCs, let Sobel train your team to meet every compliance requirement.
Learn from experts in ISO 13485, MDSAP, RDCs and biological evaluation to achieve compliance and efficiency.
The regulatory landscape for medical devices changes rapidly, with new RDCs, ISO revisions, and international requirements that directly impact compliance strategies.
Without proper training, companies face delays, rework, and even product rejections that can increase costs and damage credibility.
Expert-led training equips your team with the knowledge to anticipate changes, streamline submissions, and stay ahead of competitors.
Training your team means reducing compliance risks, accelerating submissions, and ensuring patient and user safety.
At Sobel, our specialists deliver updated training programs tailored to your business reality.
From ISO 13485 medical devices to Biological Evaluation training, Sobel provides your team with up-to-date, practical knowledge. Each course combines comprehensive content, flexible format (online or on-site), and official certification of participation.
The ISO 13485 standard defines the requirements for a quality management system specific to the medical device industry. This training helps your team understand how to implement and maintain compliance with ISO 13485:2016, ensuring consistent product quality and facilitating regulatory submissions in Brazil and abroad.
The MDSAP allows a single regulatory audit to cover multiple jurisdictions (including the U.S., Canada, Brazil, Japan, and Australia). This training provides a complete overview of the MDSAP requirements, audit structure, and best practices to prepare your company for successful certification.
RDC 665/2022 establishes Good Manufacturing Practices (GMP) requirements for medical devices in Brazil. This training explains the regulation in detail and guides participants on how to apply GMP principles in daily operations to avoid non-compliance findings during Anvisa inspections.
RDC 751/2022 defines the classification rules, notification, and registration requirements for medical devices in Brazil. This training prepares participants to correctly classify their devices, understand submission requirements, and comply with labeling and instructions for use standards.
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.
Training is a strategic investment to strengthen compliance and market readiness.
With Sobel’s training programs, your company is better prepared to handle inspections, meet regulatory requirements, and expand internationally with confidence.
Talk to us, identify the training your team needs, and let Sobel take care of the rest.
1. Who can participate in the ISO 13485 medical devices trainings?
These trainings are ideal for professionals in Regulatory Affairs, Quality Assurance, R&D, and manufacturing teams. Whether you are preparing your first submission to Anvisa or aligning your company with ISO 13485:2016 requirements, both beginners and experienced professionals can benefit.
2. What does the MDSAP training cover?
Our MDSAP training (Medical Device Single Audit Program) explains the full structure of the audit, participating countries, and best practices to prepare for certification. It is especially useful for companies that need to meet multiple regulatory authorities with a single audit.
3. Why is the RDC 665/2022 training important?
The RDC 665/2022 training provides a clear understanding of Brazil’s Good Manufacturing Practices (b-GMP) for medical devices. This is essential for companies seeking to avoid non-conformities during Anvisa inspections.
4. How does the RDC 751/2022 training help my company?
The RDC 751/2022 training prepares your team to correctly classify devices and understand notification and registration pathways. It also explains requirements for labeling and instructions for use, reducing risks of regulatory rejection.
5. Do you also provide training on MDR 2017/745?
Yes. The MDR 2017/745 training covers the European Medical Device Regulation in detail: classification, conformity assessment, technical documentation, and post-market surveillance. It is especially relevant for Brazilian companies planning to access the EU market.
6. Why invest in training on ISO 10993 and Biological Evaluation?
The ISO 10993 / Biological Evaluation training provides practical knowledge to design and execute biological evaluation plans (BEP) and reports (BER). This ensures compliance with international requirements and avoids costly delays in product registration.
7. Can I combine different trainings in one program?
Yes. Many clients request a tailored program that combines topics such as ISO 13485:2016, RDC 751/2022, and ISO 10993, depending on the needs of their Regulatory Affairs and Quality teams.
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