We carry out internal audits and supplier audits

(consultimg)

We prepare clinical evaluations according EU MDR 2017/745.

We accompany your development projects, conformity assessment procedures and support you in working with notified bodies and authorities.

We create your risk management files according EN ISO 14971.

Do you need the introduction and / or maintenance of a quality management system for medical devices?

We have years of experience in this area.

So far we have accompanied approvals in Europe, USA, Canada, Latin America, Asia – Pacific e.g. Japan, Korea, Taiwan, China, Middle East and Africa and are familiar with the procedures to be followed. For this purpose we also cooperate with local partners.