INFORMATION SECURITY
MANAGEMENT SYSTEM
TatraMed Software, s.r.o. applies an information security management system in its activities
and it ensures compliance with the principles of data protection and cyber security in accordance with applicable legislation and international standards.
This is confirmed by the certificate of the information security management system, granted by the authorized certification company 3EC International, according to international standard ISO/IEC 27001.
The certificate based on ISO/IEC 27001 is a document of compliance with the requirements of this international standard, which demonstrates the organization's ability to manage information systems and to provide related services, while consistently respecting customer needs of and regulatory requirements related to the protection of data and information systems.
QUALITY
MANAGEMENT SYSTEM
TatraMed Software, s.r.o. is committed to adhering to the principles of quality management, defined by international standards. The quality of its production processes as well as the software products is guaranteed by implementing a quality management system. Each of its medical device products is certified in accordance with European Union legislation.
This is confirmed also by the quality management certificates, issued by the authorized certification company 3EC International.
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 is a proof of compliance with the requirements of medical device regulations applied in European Union.
MEDICAL DEVICE REGULATION
Medical Device Regulation EU 2017/745 (MDR) is a new legislative regulation for medical devices to be used for clinical purposes in European Union. It specifies requirements for their safety and efficacy, clinical verification and monitoring, as well as the classification of these products according to their intended use and level of risk.
For placement on the EU market, such a product must comply with the requirements of this regulation, and the product manufacturer is obliged to carry out the relevant product certification as a procedure for determining and verifying compliance with the MDR requirements.
EU Regulation 2023/607 determines the conditions under which medical devices (classes higher than I) certified according to the legislation effective until 25/05/2021 (Medical Device Directive 93/ 24/EEC), can still be provided on the market for clinical use.
CERTIFICATES FOR
MEDICAL DEVICE MANUFACTURER
The quality certificate based on EN ISO 13485 is proof of compliance with the requirements of this international standard which defines the requirements for a quality management system for manufacturers of medical devices.
It demonstrates the organization's ability to manufacture and provide medical devices, while consistently meeting customer needs and regulatory requirements for medical devices and related services.
VALID CERTIFICATES
In addition to highly skilled workers, TatraMed Software, s.r.o. 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.
MORE
INFORMATION
INFORMATION
Medical devices regulations (EU):
International Organization for Standardization (ISO):
