TatraMed spol. s r.o. is a modern company, who applies the quality policy defined by several important international normatives. The quality of the production processes and software products is also guaranteed by the quality certificates which were granted by the international authority company Det Norske Veritas:
- Certificate CE for the product Praezis Plus 3 (group Software Medical Products for Diagnostics and Therapy Planning, class IIa),
- Certificate CE for the product TomoCon PACS 3 (group Software Medical Products for Diagnostics and Therapy Planning, class IIa),
- Certificate CE for the product TomoCon Web System (group Software Medical Products for Diagnostics and Therapy Planning, class IIa),
- Quality Management System Certificate regarding to ISO 14385:2003 for the quality management system.
All products within the above scope are analyzed and classified according to risk. To gain access to the European market they must meet the requirements of the MDD and manufacturers have to follow the specified conformity assessment procedure. Compliance of products with the MDD has to be indicated by CE-marking. After a transition period of 5 years the MDD became mandatory on June 14, 1998.
Links:
- European commission:
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
Links:
- International standardization organization (ISO)