Having a strong commitment to quality can help customers achieve both those aims and others. Parts of the ISO 13485 process involve identifying and documenting processes. For example, company ...

ISO 13485 is an internationally recognized standard for quality management systems, created by the International Organization for Standardization to ensure the safety and effectiveness of medical ...

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

The Company successfully completed Stage I and Stage II Assessments performed by the notified body, BSI, to verify it has established, and is maintaining, a quality management system that meets all ...