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.