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 […]
QR Group Explains Distribution Operations Management: What Medical Device Distributors Need to Know
Distribution Operations Management: control and efficiency in the logistics chain Managing the inventory and distribution of medical devices in Brazil requires complete visibility into inventory levels, accurate tracking, and efficient execution. QR Group offers a specialized service in the management of distribution operations, integrating technology, compliance and logistics control to ensure that your products arrive […]
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 […]
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 […]
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 […]
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 […]
Challenges for companies and inspectors in interpreting the requirements of legislation and international standards of Health Surveillance
One of the biggest challenges for companies that manufacture or import/distribute health products is understanding and/or interpreting regulatory requirements, whether they are resolutions/legislation or international standards of the Health Surveillance Agency. The applicability of certain requirements in certain segments must be carefully assessed by both companies and authorities, which makes the inspection process by health […]
