Morulaa HealthTech

EU MDR IVDR FDA Clinical Evaluation

Morulaa HealthTech is an India-based medical-device and IVD regulatory consultancy supporting coordinated market-access programs. Its services cover EU MDR and IVDR technical documentation, clinical evaluation and post-market compliance, as well as FDA registration, listing and 510(k) work. The team also supports quality systems, risk management, local representation and regulatory submissions across multiple international markets.

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Performance Evaluation Report (IVDD)

Dr. Oliver Eidel

updated over 2 years ago

15:16

Registering Your UDI in EUDAMED (Medical Device Database)

Dr. Oliver Eidel

1 K views · 8 months 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