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.