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 [...]
Feb
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 [...]
Feb
Clinical Evaluation for Medical Device Software Under the EU-MDR
By Jorn van Binsbergen, Consultant Introduction Medical device software (MDSW) can differ quite a [...]
Jul
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) [...]
Jun
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 [...]
May
CER Reviews: Successful Strategies for Sufficient Clinical Evidence
Written by: Jasmin Hunter, Senior Consultant The European Commission (EC) released an update on the [...]
Apr
Achieving Regulatory Compliance Through Clinical Evaluation
By Jasmin Hunter, Senior Consultant Clinical evaluation is a process to collect and assess all [...]
Mar
Nienke Flipsen-Maassen joins Qserve
Our Qserve CRO team is happy to announce that Nienke Flipsen-Maassen has joined them as [...]
Sep
“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 [...]
Mar
Outsourcing In Clinical Trials: Medical Devices Europe 2023
Date: 21-22 February, 2023 Location: Holiday Inn Munich City Centre, Munich, Germany Introduction The 2023 [...]
Jan