Officers and regulatory representatives of Rollerwerk Medical Engineering & Consulting
GERLACH Bettina
The conformity of the devices is checked in accordance with the QMS under which the devices are manufactured before a device is released.
Fullfillment of reporting obligations acc. Articles 87 to 91 MDR
In the case of investigational device, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
The technical file and the EU declaration of conformity are drawn up and kept up to date (MDR §10(4) and 10 (6)).
The PMS obligations are complied withaccording MDR §10 (10)
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