inteQRA GmbH

medical devices

About

inteQRA is your experienced partner for management systems and regulatory affairs in medtech. We support you hands-on, pragmatically and competently in the following areas: Management systems: - Management systems tailored to customer needs according to ISO 13485 / ISO 14001 / FDA QSR - Conducting internal audits and supplier audits QM/UM/RA support: - Outsourcing of quality and environmental management functions (PRRC, QMB, UMB) - Support with CAPAs / remediation of audit non-conformities - Conducting PMS and vigilance activities - Evaluation and verification of AI tools for regulatory knowledge management Medical devices: - Creation of technical documentation according to MDR and 510(k) - Support with risk management, validation and biocompatibility

Technologies

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Keywords

iso 13485 iso 14001 fda qsr audits iso 14971 risikomanagement prrc mdr technische dokumentation designvalidierung prozessvalidierung sterile verpackungssysteme biokompatibilitaet iso 10993 postmarket surveillance vigilanz regulatory ki medical equipment manufacturing auditing medical devices hospital & health care

Location

8 Besslerweg, Altdorf, Canton of Uri, Switzerland, 6460

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