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Case

Danish Medicines Agency inspection

Direct Derma Supplies

Challenge

  • Inspection by the Danish Medicines Agency.

  • Distributor of Class I, IIa, IIb and III medical devices.

  • Compliance with Medical Device Regulation (2017/745) and guideline no. 9364 of May 21st, 2021, Danish Guidelines for importers and distributors of medical devices.

We were recommended to reach out to Genau & More in our professional network, and after our first meeting we had no doubt that they could help us in the development our quality management  system. It has been a fantastic collaboration and everyone in the team at Genau & More worked incredibly professional and with a very critical timeline and delivery plan, which was met 100%. Our preparation in collaboration with Genau & More triggered a very good inspection with only one minor deviations We will use Genau & More as our future consultants, so we ensure, among other things, that we have a quality management system that is always ready for inspection.

Pernille Rex
Director and Head of Quality, Direct Derma Supplies ​

Solution - Proces

  • GAP-FIT assessment of quality management system, distributor's general obligations.

    • Review of medical devices from EU and non-EU countries, incl. inspection (samples) of packaging, marking, label, declaration of conformity and CE marking for Classes I, IIa, IIb and III.

    • Review, update and approve policies, processes, procedures, templates and check lists.

    • Handling and documentation of incidents, deviations, complaints and recalls.

    • Description of organization, suppliers, partners, including quality and cooperation contracts with critical suppliers.

    • Distribution chain incl. warehouse.

    • Archiving.

    • Change control and traceability.

  • Training of management and employees.

  • Representatives during inspection.

Results

  • One minor deviation during inspection.

  • Quality control and quality assurance of the company's distribution of medical equipment (without medical purpose).

  • The quality management system is always ready for inspection.

#MedicalDevices #Inspection #MDR #DanishMedicinesAgency

Kontakt os og hør mere om hvordan Genau & More kan hjælpe dig og dit firma

Sidsel Høgenhaug Jakobsen

Konsulent
GMP, MDD/MDR, Medicinsk Udstyr, Risk Management, Kvalitetssikring

Charlotte Brus Mortensen

Manager, seniorkonsulent
Kvalitetssikring, Afvigelser/CAPA, Design Control, GMP, MDD/MDR

Henrik Johanning

CEO & seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning