ISO 13485 Certification is an internationally recognized medical device standard for quality management systems (QMS). The ISO 13485 requires organizations involved in the design, production, installation, and servicing of medical devices to follow strict standards. This guidance combines customer and regulatory requirements, promising all created medical devices are safe, effective, and of high quality. In short, the ISO 13485 certificate Oupiin renewed guarantees consistent product quality and compliance with regulatory standards. 

 

 

Certification to ISO 13485 demonstrates an organization's consistent production and management of medical devices compliant with global regulations, including enforcement from the United States's FDA and the European Union's Medical Device Regulation (MDR). Unlike general quality management standards such as ISO 9001, ISO 13485 includes specific provisions for risk management, sterile device production, traceability, and maintaining documentation throughout the product lifecycle. These medical specifications uphold the company's creation and production quality to a satisfactory and safe standard.