QDC GmbH is a consulting firm specializing in quality management and regulatory issues in medical technology. The company's core activity is to support customers in the development and approval of medical products by offering solutions for quality management, product development, and regulatory requirements.
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QMS training course according to ISO 13485 with live sessions, 1:1 coaching, practical templates, asynchronous support, audit preparation and optional eQMS onboarding.
Quality management
Quality management system according to ISO 13485 for medical technology companies and suppliers, including current-state assessment, alignment with the standard, implementation and support for setting up and expanding.
MDR compliance / CE marking
MDR and CE support from preparation through targeted review and assessment of individual projects during approval and certification.
Technical File (technical documentation)
Technical documentation for medical devices, including review of existing documents, identification of missing documents, writing and improving technical files and MDR transition.
Clinical Evaluation (clinical evaluation)
Clinical evaluation of medical devices with support for clinical data, documentation, updates and linking with the risk management and the technical file.
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