Quality Management Support
A strong Quality Management System (QMS) is essential for entering and thriving in the Brazilian medical device market—especially for Class III and IV devices that require GMP certification under ANVISA’s RDC 665/2022. But aligning your system with both Brazilian and international standards can be complex.
That’s where Sobel steps in. Our tailored Quality Management Support helps your company align with ISO 13485 and ANVISA’s GMP requirements—whether you’re starting from scratch or adapting an existing system. We make compliance clearer, leaner, and more strategic.
How We Support Your Quality Management System
But what is Quality Management Support for Medical Devices in Brazil? This service helps medical device manufacturers align their QMS with RDC 665/2022, ISO 13485, and Good Manufacturing Practices (GMP) as required by ANVISA. It includes everything from internal audits to gap analysis and documentation review.
Here’s what Sobel delivers:
Conduct internal audits based on RDC 665/2022 and ISO 13485 standards
Plan and execute each audit phase: from document analysis to on-site procedure implementation
Provide an audit report detailing results, non-conformities, and corrective action recommendations
Review the Quality Manual and quality assurance procedures already in place
Offer guidance to update or implement QMS documentation aligned with Brazilian requirements
Tailor the scope to your actual regulatory needs—avoiding unnecessary steps and costs
Support communication with Anvisa in case of questions, inspections, or GMP certification audits
Why do you need this service?
We help check if your QMS is structured according to RDC 665/2022 and meets Anvisa GMP expectations.
Already certified to ISO 13485? We adapt your existing system to Brazilian requirements, so you invest only in what’s truly necessary for local compliance.
With our audit preparation and documentation support, your company is ready for internal checks and official GMP inspections with full confidence.
In fact, implementing or adapting your QMS for Brazil doesn’t have to be overwhelming.
With the right support, you can achieve full compliance, avoid regulatory roadblocks, and build a system that supports long-term success.
We go beyond just identifying gaps—we help you implement the changes needed to create a fully compliant quality management system.
Need Quality Management Support?
If you’re unsure whether your quality management system is fully compliant or need assistance with regulatory conversations, our team is here to help.
With expert QMS support for medical devices, combining regulatory insight, practical tools, and tailored guidance to align your system with Anvisa’s GMP and ISO 13485, you’ll be fully prepared for inspections in the Brazilian market.
