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 15/2014. QR Group, specialized in health product regulation, helps companies obtain this certification, ensuring compliance and efficiency of manufacturing processes. In this article, we explore how implementing quality management systems (QMS) and ISO 13485 certification are essential to ensuring successful registration and marketing of medical devices.
Impacts of ISO 13485 Certification on the Quality of Medical Devices
ISO 13485 certification is a milestone for companies seeking to ensure the quality and regulatory compliance of medical devices. The standard ensures that production processes are aligned with international quality requirements, in addition to ensuring that each device meets market expectations and regulatory standards. By complying with the standards, companies can ensure the safety and efficacy of their devices, as well as gain a competitive advantage in the market.
How ISO 13485 Relates to RDC 39/2013 and RDC 15/2014
ISO 13485 is closely linked to ANVISA Resolutions RDC 39/2013 and RDC 15/2014, which regulate, respectively, the manufacture and marketing of medical devices in Brazil. ISO 13485 certification complements these regulations, ensuring that companies meet the technical and quality requirements required by ANVISA for the approval and registration of medical devices. Compliance with these standards ensures that internal processes, such as quality control, manufacturing and documentation, meet the highest standards required for product introduction to the market.
Implementing Quality Management Systems (QMS)
Implementing a QMS is essential to ensure that medical device manufacturing processes are effective and meet regulatory requirements. A well-structured QMS not only facilitates the achievement of ISO 13485 certification, but also ensures continued compliance with national and international regulations. In addition, it helps monitor and improve the quality of the final product, increasing customer satisfaction and reducing the risk of failures or non-conformities.
How QR Group Assists in ISO 13485 Certification and Regulatory Compliance
QR Group, with its expertise in the health product regulation sector in Brazil, offers complete support for obtaining ISO 13485 certification. From the implementation of the QMS to monitoring the validation process, QR Group helps companies ensure that their products meet ANVISA requirements and international quality standards. With our regulatory consulting, companies can obtain certification quickly, minimizing risks and accelerating the market entry process.
If you are a medical device manufacturer and need to ensure ISO 13485 certification and compliance with RDC 39/2013 and RDC 15/2014, contact QR Group. Our team is ready to help you obtain certification and ensure that your products meet the highest quality and safety standards.
Source: QR Group
