Strategic advisory for projects that span several disciplines

Large projects combine several disciplines. Each card leads to a path with its stages in the order in which they are needed.

The projects

Your manufacturing is changing site, scale or supplier: how does the marketing authorization stay valid?
When a process moves to another site or to a larger scale, transfer, supplier qualification, validation, variation and batch release depend on each other.
See the path →
Your product needs CE certification under MDR or IVDR: which stages lie ahead?
On the way to the notified body certificate and beyond it, classification, technical documentation, clinical evidence, QMS and post-market surveillance depend on each other.
See the path →

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