nir-vana innovation network

Safety and technical functionality are prerequisite for clients in the medical device market. These days however, clients call for products which are convincing in every respect – among others usability optimization, ergonomic user-interfaces and designs which are aligned with their markets.

An experienced German SME develops and manufactures medical devices – entire systems serving the demanding areas of surgery, therapy and diagnostics.

The fully integrated approach offered by this company also covers the clinical processes. They are integrated into the workflow so that every element of a project is realized under the motto "Made in Germany".

In addition to its DIN EN ISO 13485:2016 certification this established partner provides service in the area of CE marking, FDA (food and drug administartion) approval, regulatory affairs, production as well as serial production and service.

The German company supports clients from their idea to their certified serial medical products which is their guarantee for success in the market.

The first and most important step is to prepare the optimal specifications and risk analysis with the client. Based on this a concept which equally addresses market expectations and certification requirements is established.

Accompanying the development is the generation of all documentation pertaining to CE or FDA guidelines.

They look for industrial partners from the field of medical devices, especially surgery, therapy and diagnostics, for technical cooperation and/or manufacturing agreement.
Other types of cooperation are also possible.

Advantages & innovations

In comparison to similar providers they offer a fully integrated approach and processes under the banner “Made in Germany”. Further advantages/innovations: - development process is swift and slender, tailored towards realizing a prompt market launch - development process is conceived, supported & accelerated intelligently and safely from the very beginning - tailored hardware & software solutions, combined with functional mechanics, specifications are translated into effective budget-conscious prototypes - as client´s central point of contact, this team will coordinate the individual know-how-providers and optimize the progress of their clients´project towards its market arrival. - generation of all documentation pertaining to CE or FDA guidelines - development services are aligned with the high standards of the FDA which enables a delivery to the clients with a fast and effective certification within a short amount of time

Stage of development

Already on the market

Partner sought

Industrial partners from the field of medical devices, especially in surgery, therapy and diagnostics, are sought for technical cooperation and/or manufacturing agreement. They are also open to other forms of co-operation. The aim and hence related tasks for collaboration is to: - generate new projects and/or project ideas together - the company performs and evaluates the proof of concept - work together in developing new analytical, diagnostic, laboratory or medical devices, for which the company offers its know-how and production capacities - the company supports in CE and FDA approval - the company provides needed production environment