Medical startups are often faced with the challenge of bringing their product to market as quickly as possible with limited personnel resources.
They often do not yet have the personnel/know how on board to set up their own complete quality management system and the required regulatory processes.
Also, it is not always planned to set up an own development and/or production department – for example, if the company is to be sold by the founders after the first successes and the product ramp-up.
In such a case, seleon can take over the role of legal manufacturer for a certain period of time or for the entire product life cycle and relieve its customer.
Such a solution can also be interesting for established and large medical device manufacturers when it comes to medical devices that complement their portfolio but are not part of their core business and they do not want to build up staff/know how for this.
Assuming the role of a legal manufacturer is not tied to the commissioning of a development and/or production project with seleon – but it makes the whole thing considerably easier, since we know the medical device we are developing and/or manufacturing best, and can thus best overview the risk structure.
In the following illustration, we have compiled all the activities required for a medical device manufacturer.
Based on the color scheme, 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 within our portfolio (dark green) and which activities should absolutely be taken over by us (brown) in order to be able to fulfill our (legal) manufacturer obligation.