Management Systems

The purpose of Medicalgorithmics Management System and Processes is to give a clear and up-to-date description of management and process principles. The organization maintains an Integrated Management System that ensures the medical products comply with global requirements. In addition, Security Management Systems have been introduced to ensure the highest standards of security.

ISO 13485, MDSAP

Quality Management System

Medical Devices Regulations

Medicalgorithmics complies with the requirements of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and the requirements of the ISO 13485 and MDSAP for the design, development and manufacture of medical devices by:

  • following defined Medicalgorithmics Integrated Management System principles,
  • maintaining and executing appropriately defined processes,
  • following the QMS related hamonized standards and regulations.

 

All safety and performance information relevant to users of Medicalgorithmics devices is available on the device itself, on its packaging and in the Instructions for Use supplied with the device by the manufacturer. In case of any questions please don’t hesitate to get in touch with our technical support at the following e-mail address technical@medicalgorithmics.com.

ISO/IEC 27001

Information Security Management Systems

 

Medicalgorithmics’s Security Management System is based on the application of the requirements of the ISO/IEC 27001 standard for information security management.