PGXperts receives certification of its quality management system according to EN ISO 13485:2016
PGXperts has successfully received certification of its quality management system according to EN ISO 13485:2016 as software manufacturer of medical devices for the provision of information for the verification of pharmacogenetic and pharmacological interactions.
„Quality and safety are the foundation of our daily work. We are very proud to have achieved this special milestone of ISO certification just eight months after our spin-off. This underscores our commitment to the highest standards to increase patient safety and enable personalized medicine.”
– Herna Muñoz-Galeano, Founder and Managing Director of PGXperts GmbH
PGXperts – Personalized Medication using Pharmacogenetics
PGXperts enables personalization of current and future medication with the aim of increasing drug therapy safety. The PGXperts system provides physicians with evidence-based applicable knowledge about the interaction between drugs and a patient’s genetically determined metabolic characteristics. With information on specific interaction risks (drug-genes, drug-drug, drug-food) the medication can be checked individually for a patient.
PGXperts interprets genetic characteristics and provides the results to the treating physician in the form of clinical consequences and concrete measures.
Quality management system according to EN ISO 13485:2016
The EN ISO 13485:2016 standard specifies the regulatory requirements for a quality management system for manufacturers and suppliers of medical devices. The aim of the ISO standard is the manufacture of safe and reliable medical devices in the EU.
