Selenium Medical renews ISO 13485 certification and successfully passes FDA and ANVISA Inspections.
Selenium Medical: ISO 13485 Audit and FDA & ANVISA Inspections
At Selenium Medical, we are committed to ensuring the quality and safety of the medical devices we outsource on behalf of our clients. Our production processes and services are rigorously controlled and adhere to the strictest standards, ensuring safe and reliable products for patients and healthcare professionals. You can download our certification here.
- ISO 13485
We have recently renewed our ISO 13485 certification, a key standard for quality management of medical devices. This certification is essential for obtaining the CE mark. In this way, it ensures that medical devices meet the safety and performance requirements of the European market. The renewal underscores our ongoing commitment to maintaining high standards of product quality and safety.
- FDA (Food and Drug Administration)
As part of an FDA inspection for Premarket Approval (PMA) for one of our clients, we achieved a result with zero non-compliances. This inspection is critical for obtaining market authorization for a medical device in the United States. It validated the conformity of our practices with the FDA’s strict requirements for Good Manufacturing Practices (GMP) and risk management.
- ANVISA
We recently reached an important milestone with our first ANVISA inspection, conducted by the Brazilian Health Regulatory Agency. The inspection went smoothly and was carried out for one of our clients with the aim of marketing medical devices in Brazil.
Committed to ensuring the quality and safety of medical devices
These successive achievements highlight the commitment of Selenium Medical and its teams. We maintain high standards of quality and safety and comply with the most stringent regulatory requirements. This also demonstrates our ability to provide our clients with reliable solutions that meet the most complex regulatory demands in an international environment. We remain fully committed to the continuous improvement of our practices in order to support our clients and their projects and contribute to patient safety worldwide.
For more information about our services or to discuss your projects, please feel free to contact us. Additionally, you can follow us on LinkedIn to discover our latest news.
