Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

Challenge

CE marking renewal under MDR

The company faced the challenge of renewing the CE marking for their products under the MDR. They required assistance with:

• conducting the literature review,
• establishing a strategy for clinical evaluation,
• and guidance in drafting the technical file documents.

Approach

Uroflowmetry clinical evaluation

QbD Group conducted a literature review to assess the current state of uroflowmetry in the medical field and to support the clinical evaluation and risk-benefit analyses of Minze’s device.

The goal was to demonstrate that the device is safe, performs as claimed, and outperforms existing market technologies.

Result

Efficient CE-marking approval

The technical file was submitted to the notified bodies and the CE marking was received within just a few weeks and even with congratulations from the authorities on the completeness of their file.