Meet our Project Partner: HTCert

HTCert (Health Technology Certification) is a European Notified Body (ID 2803) and an accredited Certification Body, operating exclusively in the field of medical devices.

HTCert is designated under the Medical Device Regulation (MDR) and accredited for ISO 13485 certification, maintaining a strong and consistent focus on medical devices. Its activities are grounded in strict compliance with European legislation, continuous regulatory expertise, and the provision of objective, impartial, and independent certification services.

Since 2023, HTCert has been an active partner of the INSAFEDARE project, contributing to dissemination and stakeholder engagement activities related to the project’s objectives and outcomes.

Within the scope of INSAFEDARE, HTCert leverages its longstanding experience in medical device certification and regulatory affairs to support communication and structured knowledge exchange between the project consortium and relevant regulatory stakeholders.

HTCert’s involvement in INSAFEDARE is further supported by its active collaboration with other European Notified Bodies, participation in regulatory forums and consortia, and membership in TEAM-NB and NBCG-Med, ensuring alignment of dissemination activities with current regulatory practices.

Key activities undertaken by HTCert within the INSAFEDARE project include:

• Regular communication with European Notified Bodies

• Collection of feedback through surveys addressing Notified Bodies’ attitudes, knowledge, and concerns regarding synthetic data

• Dissemination of INSAFEDARE updates to manufacturers and other stakeholders

• Participation in international conferences and workshops, including EFMI STC

  2025

• Active participation in INSAFEDARE consortium meetings

• Organization and coordination of monthly partners’ meetings in collaboration with EFMI

Through these activities, HTCert contributes to the effective dissemination of

INSAFEDARE results and supports the consideration of regulatory perspectives in the

project’s outputs.