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 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 […]
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 […]
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 […]
The Trends of the Health Sector in Brazil and the Impact of Technological Innovation
How Technological Innovation and Generative AI Are Transforming the Healthcare Market in Brazil The 28th Global CEO Survey revealed that business leaders are increasingly focused on reinventing their business models to generate value, ensure sustainability and drive innovation. In the healthcare sector in Brazil, this trend translates into the accelerated adoption of generative artificial intelligence, […]
