Successful Clinical Evaluation supports rapid CE marking of Minze Health's Uroflowmeter

Read more
minze-logo
CLIENT

Minze Health

Minze Health develops innovative digital products in urology to improve the health and well-being of patients with lower urinary tract complaints. These medical products are used in hospitals and at the patient’s home.

In 2022, QbD Clinical Medical Writing partnered with Minze Health to assist them in the clinical evaluation process for obtaining their CE marking under MDR.

Successful Clinical Evaluation leads to very quick CE marking of Minze Health Medical Devices
CHALLENGE

CE marking renewal under MDR

Successful Clinical Evaluation leads to very quick CE marking of Minze Health Medical Devices

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.

Sounds familiar? We can help.

Get in touch
APPROACH

Uroflowmetry Clinical Evaluation

The 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.

Successful Clinical Evaluation leads to very quick CE marking of Minze Health Medical Devices
RESULTS

Efficient CE Marking Approval

Successful Clinical Evaluation leads to very quick CE marking of Minze Health Medical Devices
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 Clinical Medical Writing 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, Medical Affairs Manager at Minze Health

Need help with your CE approval?

Discover how our Clinical and RA experts can help you, or contact us directly. We’d be happy to assist you!

  • October 24-26
  • Barcelona, Spain

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.

More Info