The medical device industry is regulated by a set of different laws, national or regional. This leads to unclarities in the demands on the product as well as in the route to product approval. The overall aim is the same; to guaranty the safety of the product in relation to its benefits. Irrespective of where globally the product is to be sold, the producer must be able to ensure and to show that the demands have been fulfilled.
There is no standard solution. Instead the producer is obliged to interpret the demands and apply them to the product and the operations. It is important early on in the product development process to define the expected use of the product since this will decide which set of rules that are to be used and how the product will be classified.
ForValue has experience from a large number of products within several sets of rules. Therefore, we are able to support you in all the steps.