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, ...
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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 ...
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Risk management files
We create your risk management files according EN ISO 14971 ...
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Conformity assessment procedure
We accompany your development projects, conformity assessment procedures and support you in working with notified bodies and authorities ...
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Clinical evaluations
We prepare clinical evaluations according EU MDR 2017/745 ...
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Audits
We carry out internal audits and supplier audits (consultimg) ...
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