Eirskrift AS

Eirskrift AS develops digital software solutions for healthcare professionals, specifically transcription and record-keeping tools. These tools assist in documenting patient interactions, fasting protocols, and psychological assessments. The software is designed to streamline administrative tasks for roles like psychologists, manual therapists, and fasting specialists, ensuring structured and secure patient data management.

Eirskrift AS is based in Norway. Since its devices fall under the scope of the EU Medical Device Regulation (MDR), they are subject to EU regulatory requirements, including registration in the EU’s eudamed database. Norway participates in the European Economic Area (EEA), aligning its regulatory framework with EU MDR for medical devices.

Eirskrift AS’s devices are listed in the eudamed database, which is the EU’s centralised registry for medical devices. This registry is used by national competent authorities, healthcare professionals, and patients to verify the legitimacy of devices under the EU Medical Device Regulation (MDR).

Eirskrift AS’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk products, such as software for transcription and record-keeping, where the risk to patient safety is minimal. Class I devices typically undergo less stringent conformity assessment procedures compared to higher-risk classes.