QR Group Explains Logistics Operations: What Medical Device Companies Need to Know
Logistics Operations: integrating compliance and efficiency in the healthcare chain Operating medical device logistics in Brazil requires absolute control of regulatory processes, inventory management, and transportation under specific conditions. QR Group’s logistics operations were developed to combine regulatory expertise with operational efficiency, offering a comprehensive service that includes planning, execution and real-time monitoring of the […]
Bonded Warehouse: Safe Storage for Healthcare Products
Bonded Warehouse: Compliance and Efficiency for Medical Devices Storing imported medical devices requires technical structure, strict management, and regulatory compliance. QR Group’s bonded warehouse service offers complete support from receipt to release for commercialization, ensuring that products are under strict control, either at the appropriate temperature or in safe areas, as required by ANVISA and […]
Dedicated Import of Medical Devices in Brazil
Integrated solutions for regulatory and logistics access Importing medical devices efficiently requires a dedicated process ranging from market research to customs clearance. QR Group performs a full dedicated import service, coordinating each step with technical and regulatory precision. Starting with the correct classification of the product, through the appointment of a local representative or qualified […]
Training in Quality Management Systems for Medical Devices
Training: Driving Quality and Compliance in the Healthcare Industry QR Group offers a series of specialized training to enhance quality systems in medical device manufacturers, aiming at compliance with standards such as RDC 665/2022, ISO 13485, ISO 14971 and CAPA processes. Our goal is to train employees to monitor risks, measure performance, and ensure continuous […]
BRH: Registration Representation for Foreign Manufacturers
Registration Holder Service: your link with ANVISA Foreign medical device manufacturers can only distribute in Brazil if they appoint a Brazilian Registration Holder (BRH). This official representative acts as a bridge between your company and ANVISA, assuming legal responsibilities, keeping the registration active, and ensuring the GMP certification necessary for regulatory compliance. Why a standalone […]
Medical Device Registration: Agile Compliance with ANVISA
Understand the Medical Device Registration Process at ANVISA Ensuring access to the Brazilian market requires a detailed regulatory process, especially in the registration of medical devices with ANVISA. QR Group’s registration service was developed to facilitate this journey, ensuring compliance, agility, and strategy for companies that want to operate safely in the health sector. Complying […]
QR Group ensures Quality System (GMP) compliance for manufacturer certification at ANVISA
Learn how QR Group’s Brazil GMP Quality System Compliance service secures GMP certification of foreign manufacturers for registration of class III and IV devices With a focus on quality system compliance, QR Group offers specialized support for GMP certification with ANVISA, essential for international manufacturers of class III and IV medical devices. What is quality […]
QR Group performs internal audits and GMP inspections for healthcare supply chain suppliers
Find out how QR Group’s internal audits and inspections ensure compliance with RDC 665/2022 and agility in product registration Focusing on internal audits, QR Group offers Good Manufacturing Practices (GMP) inspections at suppliers, preparing manufacturers to meet ANVISA requirements and ensure compliance in records. In this text, we explain the process and benefits for medical […]
QR Group offers advice on regulatory matters for product registration with ANVISA
Understand how QR Group’s regulatory affairs advice speeds up ANVISA approval for national and international manufacturers With a focus on regulatory affairs, QR Group offers complete advice for product registration with ANVISA, aiming to ensure compliance and agility in accessing the Brazilian market. In this content, we explain how this personalized advice strengthens the entry […]
Understand the Requirements of IN 242/2023 and How to Ensure Regulatory Compliance
QR Group Explains ANVISA’s New Labeling Rules: How to Adapt Your Products Normative Instruction IN No. 242/2023, published by ANVISA, brought significant changes to the labeling of personal care products, cosmetics, perfumes, and disposables. Now, whenever there is a formula modification, the “NEW FORMULA” or “NEW COMPOSITION” statement must be included in the label. If […]
