Author Archives: QserveCRO

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 [...]

On-Demand Webinar | PMCF Surveys – How to Ensure Success?

  This on-demand webinar with Purdie Pascoe dives into PMCF Surveys and how to ensure success. Covered [...]

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, MSc Joins Qserve

Nienke Flipsen, MSc Joins Qserve Our Qserve CRO team is happy to announce that Nienke [...]

Personal Health Literacy: Demystifying Readability Requirements for SSCPs Intended for Patients

Date: 26 September 2023 Time: 17:00-18:00 PM CEST | 11:00 AM – 12:00 PM EST | 8:00 [...]

“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 [...]

On Demand Free Webinar – Clinical Submission Strategy Europe and United Kingdom

This webinar will give insight into what are the differences in Clinical trial submissions in [...]

A New ISO 18969

A New ISO 18969 – “Clinical Evaluation of Medical Devices” Is on the Way: Understanding [...]

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