EAP MedTech Consulting

EU MDR

EAP MedTech Consulting is a Malaysian medical-device consultancy based in Ipoh. It specializes in the intersection of EU MDR compliance and Southeast Asian regulatory requirements, particularly Malaysian MDA registration. The firm offers direct principal involvement and supports gap analysis, technical documentation, quality systems, post-market surveillance and regulatory planning for European and Malaysian market access.

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Dr. Oliver Eidel

103 views · over 2 years ago

Is CE marking required for internally used EEG analysis software provided as a service to hospitals?

Anonymous · 2 comments

8 months ago

We are a startup providing EEG analysis services to psychiatric hospitals using software developed for our own internal use. We are ISO 13485 certified and initially planned to CE mark the software as

Accepted 2 answers

This is a really interesting situation. Under the MDR (and IVDR), the main factor is whether the software is considered to have a medical purpose and

Do distributors need to register in EUDAMED under MDR?

Anonymous · 1 comment

6 months ago

I am seeking clarification regarding the registration requirements for economic operators in EUDAMED under the Medical Device Regulation (MDR). Specifically, do distributors (as defined in MDR Article

Accepted 1 answer

Distributors do not need to register in EUDAMED. Only manufacturers, importers, and authorized representatives are required to register according to A