Our certifications
We work with a certified quality management system and, for the medical devices we design and manufacture directly, with the certifications required by Regulation (EU) 2017/745 (MDR). On this page you’ll find details of our active certificates, their scope, and how to request the complete documentation.
ISO 13485 certification
Our quality management system is certified UNI CEI EN ISO 13485:2021 by TÜV Rheinland Italia S.r.l., valid until 27 January 2028 (first certified in 2004). Our certified quality management system reflects a company culture oriented toward continuous improvement and represents a concrete commitment to customers and partners, helping to ensure high standards of safety, reliability and control at every stage of production.
CE certification under Regulation (EU) 2017/745
For medical devices in a risk class above Class I that we design and manufacture directly, we hold a CE MDR certificate issued by TÜV Rheinland Italia S.r.l. (Notified Body No. 1936), valid until 29 July 2029.
For Class I devices, such as some formats in the Dispo Gel range, conformity is attested by an EU declaration of conformity, as required by the regulation for this risk class: notified body certification is therefore neither required nor applicable.
Transition from Directive 93/42/EEC
For devices already certified under the previous Directive 93/42/EEC (MDD), the historical certificate issued by Certiquality S.r.l. remains valid beyond the nominal expiry date shown on the document, under the extension provided for by Regulation (EU) 2023/607: the conditions for the extension are met, and validity runs until 31 December 2028. The related Confirmation Letter from the notified body is available on request.
Documentation available to distributors
On request, we make available to our distributors the technical documentation needed to respond to public tenders and tender specifications: EU declarations of conformity, instructions for use (IFU), safety data sheets where applicable, and the certificates described above. Contact us to receive the material for the products you’re interested in.