Verifizierung und Validierung

TENDER DESCRIPTION

The subject matter of the invitation to tender is the provision of selected parts of the documentation that is usually required to be provided as part of the conformity assessment process, in the sense of reference documentation. The documentation subject matter is an AI application for healthcare, which, however, does not necessarily have to be a medical device. In addition to the reference documentation, further services associated with the preparation of the documentation shall be provided (see Section 1.2). For the purposes of this invitation to tender, AI applications for the healthcare system are products or systems that are defined as AI systems under the AI Act (AI-VO) or that include such a system. There must be a (foreseeable) use in healthcare. The reference documentation and the statement provided by the contractor are intended to facilitate and accelerate future conformity assessment processes and will accordingly be published by the BMG or by institutions designated by the BMG for the purpose of reuse by third parties. For details, please refer to the tender documents. The subject matter of the invitation to tender is the provision of selected parts of the…

TENDER BRIEF

TENDER DOCUMENTS