When a Class IIb device maker came to us, they were six months from a funding milestone and had never been through a full MDR submission. A rejected technical file could have delayed approval by a year and put the round at risk.
We started with a gap assessment against the relevant GSPRs and the Notified Body’s expectations, then rebuilt the clinical evaluation and technical documentation around the evidence that actually mattered. Every claim was traced back to data.
The submission cleared review with no major non-conformities and only minor clarifications, keeping the funding timeline intact. The lesson is simple: regulatory strategy set early is far cheaper than rework set late.
