QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.
In 2022, the medical writing team of QbD Group partnered with Minze Health to assist them in the clinical evaluation process for obtaining their CE marking under MDR.
The company faced the challenge of renewing the CE marking for their products under the MDR. They required assistance with:
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.
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.
Minze Health has rated the collaboration with QbD Group as being highly qualitative in terms of provinding information and knowledge, very good project management, clear and fast communication, qualitative methodology and loads of confidence in the team.
Zarha Vermeulen
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