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 […]
QR Group implements Quality Assurance and compliance systems for medical devices
See how QR Group’s Quality Assurance service ensures ISO 13485 standards and compliance with GMP and ANVISA standards QR Group offers a complete quality-assured service, helping manufacturers implement quality management systems to ensure compliance with ISO 13485, RDC 39/2013 and RDC 15/2014. In this article, we explain how this service strengthens control and efficiency in […]
How Generative Artificial Intelligence is Transforming the Brazilian Health Sector
Discover how the adoption of generative AI is driving productivity and reinvention for healthcare companies in Brazil. Generative Artificial Intelligence (AI) is becoming a crucial tool for the healthcare sector in Brazil, bringing productivity and efficiency gains to companies. According to the 28th edition of the Global CEO Survey, 58% of healthcare CEOs in Brazil […]
Management Systems Optimization: How QR Group Ensures Quality and Compliance
The Importance of Implementing a Quality Management System In the healthcare industry, an efficient Quality Management System (QMS) is essential to ensure regulatory compliance, product safety, and operational efficiency. Companies that adopt and certify their QMS according to recognized standards, such as ISO 13485, have a competitive advantage and reduce the risk of non-compliance. QR […]
QR Group Explains the Role of the Brazilian Registration Holder in Medical Device Regulation
How Foreign Manufacturers Can Market Medical Devices in Brazil For foreign medical device manufacturers to distribute their products in Brazil without having a licensed company in the country, it is necessary to appoint a Brazilian Registration Holder (BRH). This regulatory representative acts as the link between the company and the National Health Surveillance Agency (ANVISA), […]
Medical Device and In Vitro Diagnostic Registration: The Complete Guide for Foreign Manufacturers in Brazil
Understand how ANVISA regulations affect the registration of medical devices and in vitro diagnostics and how QR Group can help with compliance. Brazil, the largest medical device market in Latin America, offers great growth opportunities for international manufacturers. However, the regulatory process for medical devices and in vitro diagnostic products requires detailed attention to ANVISA […]
ISO 13485 Certification for Medical Devices: Quality Assurance and Regulatory Compliance with QR Group
Understand how ISO 13485 certification, aligned with RDC 39/2013 and RDC 15/2014, is essential to ensure the quality and compliance of medical devices in Brazil. ISO 13485 certification is a fundamental requirement to ensure that medical devices meet the strict quality standards required by the market and Brazilian regulations, such as RDC 39/2013 and RDC […]
QR Group Explains How to Sell Class III and IV Medical Devices in Brazil: Certification and Compliance Requirements
Learn how to obtain the GMP certification required to register Class III and IV medical devices with ANVISA with the help of QR Group. To market Class III, Class IV or IVD medical devices in Brazil, it is essential that foreign manufacturers obtain Good Manufacturing Practices (GMP) certification from ANVISA. This process is crucial to […]
