Manufacturing

The transfer of manufacturing information starts well before the end of development but is intensified when approaching production of the first series.

We support our customers in all design transfer activities. Ensuring that a product can be manufactured is important for us and for you as a customer.

We can also support our customers in setting up their small scale production. This is a cost-effective way to build systems for clinical investigations and customer evaluation. We have experience from setting up process validated production including clean-room, sterilization and accompanying testing.

Every product has its own challenges concerning manufacturing and assembly. We have been involved in low and high volume manufacturing, packaging and sterilization processes.

We have experience from validating and manufacturing processes and products according to GxP and cGMPs. Our network consists of manufacturers which have been in this business for a long time. We have been involved in every step from factory and site acceptance tests through installation, operational and performance qualification.

Hotswap works with the manufacturing team to make sure that information is clear and that adjustments for production procedures are made. Sometimes we are also involved in designing and building manufacturing and testing equipment for the product.