Statistics indicate that approximately 4,500 medical devices and drugs get taken off the market owing to recalls. Just as managerial reviews of ISO 13485 processes can prevent persistent issues, a ...

InnoVoyce, a leading medical technology company, proudly announces its ISO 13485:2016 certification, underscoring its ...

which harmonizes U.S. requirements with global standards through the adoption of ISO 13485 for medical devices. ISO 13485 is also strongly recommended and widely used in the European Union.

ISO 13485 is a stringent, internationally recognized standard that sets the requirements for quality management systems in the medical device industry. To achieve this certification, companies ...

Stratasys Direct facility in Tuscon, Arizona, achieves ISO 13485 certification, and is now formally recognized for safety and reliability.

By achieving ISO 13485 certification, Stratasys Direct is formally recognized for its safety, precision, and reliability of its 3D-printed components. This certification addresses critical regulatory ...