Category Archives: Blog

Introducing Qserve Learn: A dedicated online learning platform for the Medical Device and IVD sector!

Are you ready to take your skills to the next level and stay ahead in [...]

Meet Claire Borde – Qserve CRO’s Experienced Sr. Clinical Project Manager

At Qserve CRO, we are proud to have a team of highly skilled professionals dedicated [...]

Clinical Evaluation for Medical Device Software Under the EU-MDR

  By Jorn van Binsbergen, Consultant Introduction Medical device software (MDSW) can differ quite a [...]

Understanding the MDCG 2024-10 Guidance: Will it really help patients that need orphan medical devices?

By Bianca Lutters, Head of Clinical Operations This week, the Medical Device Coordination Group (MDCG) [...]

Equivalence Possibilities for Implantable and Class III Devices Under the EU MDR Considering the MDCG 2023-7 Guidance

By Patrícia da Silva Perez, Senior Consultant The claim of equivalence allows manufacturers to use [...]

CER Reviews: Successful Strategies for Sufficient Clinical Evidence

Written by: Jasmin Hunter, Senior Consultant The European Commission (EC) released an update on the [...]

Achieving Regulatory Compliance Through Clinical Evaluation

By Jasmin Hunter, Senior Consultant Clinical evaluation is a process to collect and assess all [...]

Nienke Flipsen-Maassen joins Qserve

Our Qserve CRO team is happy to announce that Nienke Flipsen-Maassen has joined them as [...]

“Monitoring of medical device clinical trials” in accordance with ISO14155 and EU MDR

If you are a medical device manufacturer/sponsor starting a clinical trial, you have the obligation [...]

Outsourcing In Clinical Trials: Medical Devices Europe 2023

Date: 21-22 February, 2023 Location: Holiday Inn Munich City Centre, Munich, Germany Introduction The 2023 [...]

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