inteQRA GmbH

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