A strategic guide to the MDR technical file challenge: notified body review, the three-strike system, the cost of non-compliance and how to get it right.

What two decades of building medical devices teaches about EU MDR readiness, from Obodux co-founder Simon Taylor.

A manufacturer can have hundreds of documents and still struggle to answer a simple question: are we ready for assessment? Here is how to find out.

Devices still on the EU market under MDD, AIMDD and IVDD certificates face fixed end dates in 2027, 2028 and 2029. Here are the dates and conditions that apply.

Emails, spreadsheets and shared folders create blind spots. Manual tracking misses changes, and audits expose the weaknesses.

MDR has raised the cost, time and risk of technical file preparation. This brief sets out the seven critical challenges and the strategic imperatives for getting it right.

UKCA documentation often shares evidence with a CE pack, but labelling, conformity artefacts and the reviewing body can differ. Here is how to keep dual-mark work controlled.

MDR expects a coherent, navigable evidence pack, not a folder of disconnected Word files. Here is how to structure your technical file once and keep it maintained.