Medical device industrialisation and contract manufacturing

You are. The legal manufacturer is whoever places the device on the market under their own name and signs the declaration of conformity. MeDev Consulting acts as contract manufacturer, under your quality system and a quality agreement that sets each party's responsibilities.

Yes. As legal manufacturer you need your prior operating licence, and the contract manufacturer holds its own as a manufacturer of devices for third parties. Both are required and complement each other.

The formal step from development to production: specifications, drawings, work instructions, tooling and acceptance criteria are frozen in the device master record (DMR). Without it, every batch reinterprets the design and the conformity demonstrated in the file is lost.

Those that cannot be fully verified on the finished device: sterilisation, package sealing, welding, moulding or cleaning. They are validated with IQ/OQ/PQ protocols and revalidated when the process, equipment or material changes.

With batch records for every critical component, UDI identification, batch manufacturing records (DHR) and incoming, in-process and final inspection control. It is what makes it possible to locate and recall product from the market if ever needed.

Yes. We coordinate sterilisation with qualified sterilisers, including its validation, and storage and distribution under controlled conditions, with traceability down to the end customer.

It all depends on the type of device: we cannot set a volume without knowing it. Send us the information about your device and we will indicate a reasonable minimum quantity based on our experience.