Cyber Security in medical device software
The protection of sensitive patient data or life-supporting systems against unauthorized access is of central importance in view of advancing networking in medical technology.
The protection of sensitive patient data or life-supporting systems against unauthorized access is of central importance in view of advancing networking in medical technology. Therefore, infoteam Software AG recommends to take measures for cyber security already during the conception and development of medical device software.
Our services include
Software development in compliance with standards (agile) for medical devices according to MDR, IVDR FDA and CFDA
Cyber Security for medical devices according to ISO 27000 family (e. g. 27001, 27005, 27034)
Cyber Security for medical devices according to IEC 62443
Software development for medical devices in accordance with FDA Cyber Security Guidelines and BSI guidelines
Certified quality management according to ISO 13485
Own development process according to IEC 62304
Risk management according to ISO 14971
Usability Engineering according to IEC 62366-1
Especially for medical technology and laboratory automation, our certified quality management system according to ISO 13485 guarantees the security of your software against attack according to FDA and MDR or IVDR specifications. In combination with risk management and usability engineering, our development process focuses on the protection of highly sensitive medical data and critical processes in the clinical environment right from the start. In this way, possible security risks can already be identified, evaluated and eliminated during software planning and development in compliance with the applicable norms and standards.