Fürth, Germany, December 12, 2022. HMG Systems Engineering has successfully certified its quality management system by TÜV Rheinland according to EN ISO 13485:2016. The IT company thus meets the highest regulatory requirements for a quality management system for the production of software as a medical device. The scope of the certification includes the design and development, manufacture, installation and distribution of software for the provision of information for the verification of pharmacogenetic and pharmacological interactions.
“This ISO certification is proof of our commitment to the highest standards of product performance, quality, and patient safety. It is an important milestone on the road to enabling Personalised Medication.
– Herna Muñoz-Galeano, Managing Director HMG Systems Engineering GmbH
The PGXperts system developed by HMG provides physicians with evidence-based and rapidly applicable knowledge about the interaction between drugs and a patient’s genetically determined metabolic characteristics. With information on pharmacogenetic and pharmacological interaction risks, medication can be reviewed individually for a patient and drug therapy safety can be increased. PGXperts interprets relevant pharmacogenetic information and provides the results to the treating physician in the form of concrete measures and clinical consequences. This enables the personalisation of current and future medication.
The EN ISO 13485:2016 standard “Medical devices: Quality management systems – Requirements for regulatory purposes” addresses the requirements that medical device manufacturers and providers must meet in developing, implementing, and maintaining quality management systems for the medical device industry. In 2021, the standard was harmonised under the MDR. The European Medical Device Regulation (MDR) is a new set of regulations governing the manufacture and distribution of medical devices in Europe, replacing the Medical Device Directive (MDD) from May 2021.
