In the Industrialise stage you scale-up the product manufacturing and assembly processes in readiness for launch. We can help you with the design transfer to manufacturing by managing the handover of the design history to the production team, supporting scale-up activities such as supplier management and process design. We can then support you through the qualification and validation process for manufacturing and assembly of your product.

We work with Design Controls ISO 13485:2016, Risk Management ISO 14971, Usability ISO 62366 and cGMP (Pharmaceutical Good Manufacturing Practice)