ISO 13485 is an international standard related to Quality Management System for Medical Device. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This applies not only to companies that construct, produce, and service medical devices, but also to organizations distributing and using them. ISO 13485 aims to increase the organization's reputation in the eyes of customers and authorities. ISO 13485 is not a product standard, it is a process standard which requires to comply with all relevant product and service oriented technical standards and regulations. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. It supports the reduction of unexpected risks with regard to the devices and enhances their management.
Benefits of ISO 13485 Certification:
- Tranparency and clarity of internal processes
- Minimize and manage risks
- Improve performance quality
- Time and cost savings
- Emphasize competence