Qualimed operates under the most demanding certifications in the medical device sector. Not as a milestone: as a daily routine, verified by third-party bodies.
It ensures cyclical control of the entire process: from the selection of materials to end-customer satisfaction. The certification is maintained through periodic audits by accredited bodies.
For the wearer this means: every stage leading to your lens is controlled, documented and verified by third parties.
The standard specific to quality in the medical device sector: it governs design, manufacture, control and placing on the market.
For the wearer this means: your coloured lens is manufactured to the same standards as any medical device, because that is what it is.
Certification of the Production Quality Assurance System (Annex V, Directive 93/42/EEC) for contact lenses and related solutions, issued by Notified Body ICIM S.p.A. no. 0425. Validity extended to 31 December 2028 (EU Reg. 2023/607), with the transition to Regulation (EU) 2017/745 (MDR) in progress.
For the wearer this means: the lenses you wear are fully compliant and lawfully marketed in the EU, while certification under the new regulation proceeds with the same body that has been auditing us since 2012.
Desìo lenses have obtained 510(k) clearance from the Food and Drug Administration, a requirement for sale in the United States, where contact lenses, including cosmetic ones, are regulated as medical devices.
For the wearer this means: the very product you wear has passed the scrutiny of the American regulatory authority.