Assumption of the role of legal manufacturer
Medical technology start-ups are often faced with the challenge of bringing their product to market as quickly as possible with limited human resources.
They often do not yet have any personnel / know-how on board to set up their own complete quality management system and the required regulatory processes.
Nor is it always planned to set up a separate development and / or production area - for example, if the company is to be sold by the founders after the initial successes and the ramp-up product.
In such a case, seleon can take on the role of legal manufacturer for a certain period of time or for the entire product life cycle and relieve its customers.
Such a solution can also be of interest to established and large medical device manufacturers when it comes to medical devices that complement their portfolio, but do not belong to the actual core business, and you do not want to build up staff / know-how for it.
Taking on the role of legal manufacturer is not tied to the commissioning of a development and / or production project at seleon - but it makes the whole thing considerably easier, as we know best the medical product we have developed and / or manufactured, and the risk structure as such can best overlook.
In the following figure we have put together all the activities required for a medical device manufacturer.
Based on the color design, you can see which activities should always remain with the manufacturer (blue), which activities we can cover with the help of our large, qualified network (light green), which activities fall into our portfolio (dark green) and which activities are essential should be taken over by us (brown) in order to be able to meet our (legal) manufacturer obligation.