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Project

Notified Body Increased Capacity (NoBoCap)

NoBoCap will increase the capacity of notified bodies (NB) quickly and sustainably. At its core is a new data platform on which two
verticals are grafted: a market intelligence and a capacity development verticle. In the first vertical, market operators (MO) and NB can
exchange information. On the one hand, this will enable NBs to correctly estimate the capacity needs for the next 2-3 years. On the
other hand, MO will be able to identify NBs that are specialised in their devices and having the necessary capacity at the right time.
NBs and MOs from around the world will define, through surveys at the beginning of this project, a minimum viable product for this
vertical, including the procedures to be used to maintain privacy, confidentiality, and non-competitiveness. Other stakeholders,
including patients, will also be surveyed to align and prioritize end-user needs for front-end device offerings and their certifications.
The second vertical will also be built based on surveys. This vertical will coordinate the need and supply of training to create a
smooth flow of suitably qualified personnel from the knowledge institutions and the MO to the NBs. To meet the capacity needs
within the NBs in the short term, centralized educational tools will be created that will relieve the internal trainers of the NBs on the
one hand and increase the capacity of the educational tools on the other hand. This will lead to a net migration of personnel from the
MO and knowledge institutions to the NB. To make this sustainable and to increase the knowledge within the MO about what is
needed to guide their devices through the certification process as smoothly as possible, appropriate centralized training tools will be
created. Combined with active recruitment at the global level of the right candidates to the MO and knowledge institutions, and
active encouragement to establish new notified bodies, this will lay a good foundation to guide the careers of new experts to the
NBs.

Date:1 Mar 2023 →  Today
Keywords:notified bodies
Disciplines:Cardiology