HTCert was established in 2016 as a certification body dedicated to activities exclusively connected with healthcare and medical devices. We were a team of experts in the field of healthcare, with broad knowledge on the medical devices industry and technologies and of the conformity assessment activities. Nowadays, a wide network of experts is already compiled, including professionals that have been part of the development of European medical devices’ market through the last 30 years, as well as professionals that have specialized knowledge of sophisticated and innovative technologies and devices.
On 2019 HTCert was authorised as a Notified Body according to the European Medical Device Directive 93/42/EEC, with identification number 2803, and simultaneously as an accredited Certification Body and since then it offers its services in the medical devices industry strongly committed to the
- Respect of European legislation
- Updated expertise for our activities
- Objective, impartial and confidential services
In July 2023 HTCert was also designated according to MDR, expanding its range of services but always focusing in the sector of medical devices.
Our vision remains unchanged to be a reliable and useful link in the European chain that ensures health and quality of life for all.
