ISO13485:2003 is the International Standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems.
1. EC design examination Certificate in accordance with Annex II, Section 4 of Directive 93/42/EEC
2. Certificate for Quality Assurance EN ISO 13485/07.2003
3. Certificate for the Quality Assurance System Annex II, Section 3 of the Directive 93/42/EEC
4. Certificate of Registration ISO 13485:2003 CMDCAS