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DirectoryBusiness & Technical ServicesManagement ConsultingAarauQDC GmbH
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QDC GmbH

Summary

About the company

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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Products & services

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✓ Offered6
QMS training course according to ISO 13485
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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Location

Laurenzenvorstadt 61
5000 Aarau
Opening hours
Mon
08:00 - 17:00
Tue
08:00 - 17:00
Wed
08:00 - 17:00
Thu
08:00 - 17:00
Fri
08:00 - 17:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Limited Liability Company
UID
CHE-173.443.090
Founded
2019 · 7 years
Last commercial register change
March 26, 2024
Employees
11 to 20

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