Quality Management for Software-Projects

In the field of translational research the usage of the developed systems for patient treatment/diagnosis is a key factor for success. Therefore it is important that new developments and ideas can be applied to patients directly, but nevertheless the patient safety needs to be guaranteed.

In Germany the Medizinproduktegesetz (MPG) obliges that medical devices need to fulfill the essential requirements before they can be placed on the market or used for patient treatment. The proof of compliance with these requirements may be established by being conformal to harmonized standards. One method to prove this conformity is the certification of a QM system under which the medical devices are developed.

In March 2010, a new MPG version has been released which classifies stand-alone software as independent medical device (MPG § 3) Therefore systems developed in our division have to be classified as medical devices. Since the MPG also applies for medical devices which are solely developed for in-house usage (MPG §12) our systems have to meet the requirements and be conformal to the standards like any other commercial medical device.

For this reason a Quality Management according to DIN EN ISO 13485 was introduced in 2012 and certified by TÜV SÜD Product Service GmbH in September 2013. It applies to all developed software projects in our department which are or should be used on patients.

Next to the DIN EN ISO 13485, a few more standards must be fulfilled:

  • DIN EN ISO 14971: Medical devices - Application of risk management to medical devices
  • IEC 62304: Medical device software -- Software life cycle processes
  • DIN EN 62366: Medical devices - Application of usability engineering to medical devices    
  • Medical Device Directive 93/42/EEC resp. 2007/47/EC


We underwent the following cycle – and are still in it:

With our QM System we can develop quality assured software within our division, guarantee the translation of research outputs to clinical practice and simplify the exchange with industrial collaboration partners.

People involved:
Rolf Bendl
Christian Bierstedt
Kim Löpprich

Jan Rüppell


You want to know more? …. Get in touch with Prof. Dr. Rolf Bendl 


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