Quality Management System in Brazil
Aligning your quality management system with both Brazilian and international standards can be complex and time-consuming. We help medical device manufacturers meet RDC 665/2022 and ISO 13485 requirements—making compliance simpler and faster.
- Manufacturers seeking to enter or maintain compliance in the Brazilian market.
- Companies aiming to obtain or renew Anvisa GMP certification.
- Organizations already certified under ISO 13485 that need to adapt to RDC 665/2022.
- Quality and regulatory teams looking for external expertise to validate or optimize their systems.
Whether you’re starting from scratch or adapting an existing system, our support makes compliance clearer, leaner, and more strategic.
Why do you need this service?
Implementing a compliant Quality Management System is mandatory for Anvisa GMP certification under RDC 665/2022.
Aligning your QMS with ISO 13485 and Brazilian requirements ensures consistency, traceability, and readiness for inspections.
Early identification of gaps reduces the risk of non-conformities, certification delays, and costly rework.
Build a compliant and efficient Quality Management System in Brazil
Our experts guide you through every stage—from document analysis and gap identification to audit preparation—so your company can be inspection-ready and confident for GMP certification!
Technical expertise, regulatory insight, and customized guidance.
Which service best supports your quality management system?
Depending on your company’s goals and regulatory stage, you can request an internal audit, a gap analysis against RDC 665/2022, or a gap analysis against ISO 13485.
Internal Audit
Best if you need an independent, structured assessment to verify compliance, evaluate documentation, and identify non-conformities in your Quality Management System.
Gap Analysis (RDC 665/2022)
Ideal for companies preparing for Anvisa GMP certification. This analysis checks your QMS against Brazilian requirements and highlights what needs to be improved before an inspection.
Gap Analysis (ISO 13485:2016)
Recommended if you want to align your QMS with international standards. It helps ensure your processes, documentation, and quality manual meet ISO 13485 expectations.
From targeted assessments to complete system reviews, Sobel provides the structure your company needs to achieve a compliant and effective Quality Management System in Brazil.
RDC 848/2024 Training
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.
MDR 2017/745 Training
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 Training
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.
Related
Services
A strong Quality Management System in Brazil is essential to access and thrive in the local medical device market. You can also count on regulatory support to complement your QMS strategy:
Biological Evaluation
Complete Biological Evaluation for devices, aligned with ISO 10993 for safety & compliance.
Clinical Evaluation
Clinical Evaluation aligned with Guidance nº 31/2020 – version 2, ensuring device safety.
Brazilian Registration Holder
Navigate market access in Brazil with Sobel as your device registration holder.
Achieve full QMS compliance with expert support
A compliant Quality Management System in Brazil is the foundation of every successful medical device operation. At Sobel, we go beyond identifying gaps—we help you understand and apply the right standards with clarity and confidence.
Our experts combine local regulatory knowledge and international experience to support your company in every phase!
1. What is a Quality Management System (QMS) for medical devices in Brazil?
A Quality Management System (QMS) is a structured set of policies, processes, and procedures that ensure medical devices are consistently designed, manufactured, and controlled according to regulatory and quality standards such as ISO 13485 and RDC 665/2022.
2. Is a QMS mandatory to sell medical devices in Brazil?
Yes. For Class III and IV devices, Anvisa requires companies to implement a compliant QMS and obtain GMP certification under RDC 665/2022 before registration approval. Even Class I and II devices benefit from structured quality management practices to maintain traceability and safety.
3. What is the difference between ISO 13485 and RDC 665/2022?
ISO 13485 is an international standard for medical device quality management, while RDC 665/2022 defines Brazil-specific requirements for Good Manufacturing Practices (GMP). A compliant QMS in Brazil must align with both to ensure global consistency and local regulatory approval.
4. What kind of support does Sobel provide for QMS compliance?
Sobel offers three complementary services: Internal Audits, Gap Analysis (RDC 665/2022), and Gap Analysis (ISO 13485:2016). Our experts assess your system, identify non-conformities, and deliver actionable guidance to help you reach full compliance efficiently.
5. Does Sobel help implement corrective actions or new procedures?
Our scope focuses on assessment and guidance.
6. Why choose Sobel for Quality Management System support in Brazil?
Sobel combines deep regulatory knowledge of Anvisa requirements with international expertise in ISO 13485 quality management systems. We make compliance clearer, faster, and more strategic—helping you prepare for audits, achieve certification, and maintain long-term quality consistency.
