SoteDigi Oy and the contracting entities listed in Annex 20 are acquiring MDR-based IT services (Medical Devices Regulation, EU Regulation 2017/745).

The procurement is divided into two (2) areas:

1. Application Development

2. MDR Consulting.

The subject of the procurement is described in more detail in this call for tenders and its annexes, in particular Annex 1, "Subject of the procurement".

The procurement will form a multi-supplier framework agreement. Internal procurement within the framework agreement will be carried out through lighter tendering. The invitation to tender for lighter tenders describes in more detail the content and terms of the individual contract. Selected vendors for component 1 Application Development cannot be selected for component 2. The suppliers selected for component 1 must be independent. The requirement is based on the fact that part 2 includes e.g. auditing of implementation of component 1.

This area includes the design, specification, service design, programming, integration, testing and support and maintenance services for medical devices and their back-end services related to the SoteDigi Oy resident digital services service package. In addition to the services described above, the contract may also provide similar work for software that is minor in medical devices and is not covered by the MDR. This area is described in more detail in the annexes to the invitation to tender, in particular in Annex 1 Subject of the contract.

The field includes consulting on the development of SoteDigi Oy's medical equipment. This area is described in more detail in the annexes to the invitation to tender, in particular in Annex 1 Subject of the contract.