Is (or can be) neo4j considered compliant with IEC 62304 for health data and medical devices?

I must start the development of a brand new application in the e-health sector.

We will need to store millions of data regarding patient, analysis details, medical responses and so on.

The data comes from medical devices, which are compliant with the regulation ( IEC 62304 is for both EU and US).

If I would like to store neo4j to store the data (Imagine a cardioholter, an ecg, or any kind of data you can collect with an autonomous external device) and the response from a phisician which analyze the data and provide both the response and the clinical suggestions just in time, can I use Neo4j Enterprise edition to store and manage those data with an heavy security support, high concurrency, load balancing and disaster recovery support, as described by the IEC 62304???

There is any documentation that explain this use case or any companies that have already used the product in a similar manner?

Any help or suggestion will be appreciated.