Do you need support with the conformity assessment or documentation of the research and development of your medical devices?
We advise you on the following topics:
Approval of medical devices EU and global
So far we have accompanied approvals in Europe, USA, Canada, Latin America, Asia - Pacific e.g. Japan, Korea, Taiwan, China, ...
Quality management system for medical devices
Do you need the introduction and / or maintenance of a quality management system for medical devices? We have years ...
Risk management files
We create your risk management files according EN ISO 14971 ...
Conformity assessment procedure
We accompany your development projects, conformity assessment procedures and support you in working with notified bodies and authorities ...
Clinical evaluations
We prepare clinical evaluations according EU MDR 2017/745 ...
Audits
We carry out internal audits and supplier audits (consultimg) ...