Specific Services
Our services are designed to support all key participants in the healthcare ecosystem - from institutions and policymakers to industry leaders, healthcare providers, and patients. We work across the entire value chain to help ensure that innovation, access, and ethical standards are translated into real impact for people.
Clinical performance study & clinical evaluation
#Conformity assessment obtaining by NB
1
Determination of the IVD class
2
Clinical trials for all IVDs, except for class A, non-sterile
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Preparation of a design for clinical trials for each IVD, except for non-sterile IVDs, according to the requirements of Regulation 2027/746.
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Preparation of a clinical performance trial plan.
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Preparation of documentation for obtaining permission from the BDA to conduct clinical trials for each individual IVD, except for non-sterile IVDs.
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Management of clinical trials for each individual IVD, including contact with laboratories conducting the studies, preparation of documentation for each patient, data collection and analysis.
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Preparation of protocols, data collection, analysis, clinical evaluation.
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Preparation of a Clinical Performance Trial Report for each IVD, a mandatory part of the documentation for conformity assessment of the MIID.
3
Performance evaluation plan for each IVD (by dossier)
4
Consultation on Scientific Validity Report
5
Consultation on Analytical Activity Report
6
Clinical Performance Evaluation Report
7
Creation of Basic UDI-DI
8
Preparation of technical dossier and associated documents for preparation of declaration of conformity by manufacturer for non-sterile class A IVD
9
Preparation of a package of documents for all MIID, except non-sterile class A for application for conformity assessment by the NO
10
Consultation on documentation for additional information that the manufacturer provides to the NB (Notified body): label, instructions for use, sterility
11
Search and contact with a Notified Body on the territory of the EU, collection of quotes, inquiry
12
Search and contact with laboratories in the EU to conduct MIID tests related to conformity assessment, request for a quote, preparation of documentation
13
Entry of documents in the Notified Body, collaboration
Services to a Manufacturer After Receiving a Conformity Assessment
Post-market surveillance after CE marking
HTA dossiers preparation
Conformity assessment obtaining by NB
Clinical performance study & clinical evaluation