Manufacturing agreement
Dripmate A/S has entered into an agreement with Tronex A/S for the control of all components, the assembly of Dripmate’s product and the shipment of the final products directly to Dripmate’s customers.
As part of this collaboration, Dripmate A/S will educate the Tronex employees to handle the Dripmate product, as only authorized employees are allowed to handle Dripmate’s products at each production stage. Dripmate undertakes the teaching and the approval of the individual employees.
Before the final delivery to Dripmate’s customers, Dripmate’s internal and external representative of QA/RA must review and compile the Certificate of Conformance (CofC) for each batch and, upon approval, make release for sale, as Dripmate’s product is defined as a Medical Device, classified as “IIa”.
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