TatraMed Software, s.r.o.. is a company that is committed to adhering to the principles of quality management defined by international standards. The quality of the production processes as well as the software products themselves is guaranteed by implementing a quality management system.
This is confirmed also by the quality certificates issued by the authorized certification company 3EC International. Each product (medical device), which is certified this way, has been shown to comply with the requirements of the MDD 93/42/EEC Directive and it also must be marked with a CE mark based on precisely specified rules.
THE CE MARK
Using the CE Mark the manufacturer notifies the consumer that he takes on the responsibility to ensure that the product meets all applicable requirements of the harmonized EU legislation.
The CE Certificate issued for a medical device or a tool is a proof of compliance with the requirements of the EU Directive MDD 93/42/EEC amended by the directive 2007/47/EC.
MEDICAL DEVICE DIRECTIVE
Medical Device Directive 93/42/EEC (MDD) is a document issued by the European Commission, which contains a set of requirements for products designed for medical purposes (so called medical devices) and the classification of these products based on their purpose and risk level.
Before this product can be introduced to the EU market, it must meet the requirements of this directs and its manufacturer is obliged to perform the respective certification of the product, i.e. procedure to determine compliance with said requirements of the MDD.
FOR THE QUALITY MANAGEMENT SYSTEM
The quality certificate based on EN ISO 13485 is proof of compliance with the requirements of the international standard EN ISO 13485.
This standard defines the requirements for the quality management system, through which the organization can proof its ability to produce medical devices and provide related services, while it also thoroughly meets the customer’s and regulatory requirements relating to medical devices and related services.
In addition to highly skilled workers, the TatraMed Software, s.r.o. Company has successfully completed certifications that are performed by an internationally acknowledged independent authority. These certificates confirm that its products meet all the requirements and that everything complies with the requirements of the European standard.
Declaration of conformity for TomoCon PACS
Medical devices regulations (EU):
International Organization for Standardization (ISO):
Slovak Technical Standards (ISO):