Dear all,
I am looking for EU based manufacturers that have integrated the IMDRF AE coding not only in their vigilance process, but also in other processes in their QMS, such as risk management, clinical evaluation, CAPA etc.
Your experiences are of interested to the regulatory community with the intention to be shared during the RAPS EU Convergence in Berlin, May 6-7 2024.
Can you help out, sent me a DM on LinkedIn.
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Robert van Boxtel
Principal Consultant Medical Device Project B.V.
MDProject
Alphen a/d Rijn
Netherlands
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