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 […]
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 […]
Why is Good Manufacturing Practices Training Essential in Brazil?
QR Group Explains How Training Can Be a Competitive Advantage in the Healthcare Market In Brazil, where the healthcare sector is constantly evolving, companies that invest in good manufacturing practices stand out for the quality and safety of their products. QR Group, a specialist in regulatory consulting and product registration with ANVISA, reinforces the importance […]
In Vitro Diagnostic Devices: Update on ANVISA’s Petitioning System under RDC 830/2023
QR Group provides guidance to international manufacturers on new regulatory requirements for in vitro diagnostic devices and how to adapt to RDC 830/2023 ANVISA will carry out an important update to its electronic petitioning system between May 29 and June 3 to comply with RDC 830/2023, which establishes new rules for the risk classification, registration, […]
