Full scope Medical Device CRO

Clinical trials are a keystone during the development and life cycle of your medical device. Compliance with the Medical Device Directive, and in the near future the Medical Device Regulation, is vital to be able to obtain and/or maintain CE-marking.

Full scope Medical Device CRO

Clinical trials are a keystone during the development and life cycle of your medical device. Compliance with the Medical Device Directive, and in the near future the Medical Device Regulation, is vital to be able to obtain and/or maintain CE-marking.

New service:
PMCF surveys for remote data collection

Due to the COVID-19 pandemic, many clinical investigations other than those aimed at management of the disease have been postponed or suspended. The EU Medical Devices Regulation (MDR) 2017/745 reinforces the rules on clinical evidence. In practice, this means that for many devices currently on the market additional clinical data will have to be generated to enable CE-marking under the MDR.
Clinical investigations are not the only method of clinical data collection. Depending on the clinical data gap that needs to be addressed, post-market clinical follow-up (PMCF) surveys can be a valuable data collection tool. In fact, user surveys (collecting of user feedback) are listed in the MDR as a valid method of post-market clinical data collection.

Wiebe Postma Qserve CRO

Benefits of PMCF surveys:

  • Performed fully remotely
  • Quick execution
  • No ethics review or competent authority approval required
  • High quality data can be obtained
  • Low cost
Contact us

New service: PMCF surveys for remote data collection

Due to the COVID-19 pandemic, many clinical investigations other than those aimed at management of the disease have been postponed or suspended. The EU Medical Devices Regulation (MDR) 2017/745 reinforces the rules on clinical evidence. In practice, this means that for many devices currently on the market additional clinical data will have to be generated to enable CE-marking under the MDR.
Clinical investigations are not the only method of clinical data collection. Depending on the clinical data gap that needs to be addressed, post-market clinical follow-up (PMCF) surveys can be a valuable data collection tool. In fact, user surveys (collecting of user feedback) are listed in the MDR as a valid method of post-market clinical data collection.

Benefits of PMCF surveys:

  • Performed fully remotely
  • Quick execution
  • No ethics review or competent authority approval required
  • High quality data can be obtained
  • Low cost
Contact us
Wiebe Postma Qserve CRO

How we work

PHASE

CLINICAL EVALUATION

To be able to initiate an activity of clinical data collection, the clinical evaluation needs to be in place.

Read more
QServe-phase-clinical evaluation

PHASE

CLINICAL STRATEGY

The clinical questions that originate from the clinical evaluation feed into a detailed clinical strategy

Read more
QServe-phase-clinical strategy

PHASE

PROJECT PLANNING

Based on a well-developed clinical strategy, planning of the actual clinical operations is started. Planning involves the set-up of essential documents, allocation of resources and selection of partners.

Read more
QServe-phase-planning

PHASE

STUDY CONDUCT

Operational excellence is in our DNA. In the phase of conducting your clinical activities the study sites will be initiated, first patients will be enrolled and clinical data is collected

Read more
QServe-phase-conduct

PHASE

CLINICAL DATA

Our clinical data managers and statisticians analyse the collected clinical datapoints and provide you the results. Our medical writers can help write study reports and publication

Read more
QServe-phase-clinical data

How we work

QServe-phase-clinical evaluation

PHASE

CLINICAL EVALUATION

To be able to initiate an activity of clinical data collection, the clinical evaluation needs to be in place.

Read more
QServe-phase-clinical strategy

PHASE

CLINICAL STRATEGY

The clinical questions that originate from the clinical evaluation feed into a detailed clinical strategy

Read more
QServe-phase-planning

PHASE

PROJECT PLANNING

Based on a well-developed clinical strategy, planning of the actual clinical operations is started. Planning involves the set-up of essential documents, allocation of resources and selection of partners.

Read more
QServe-phase-conduct

PHASE

STUDY CONDUCT

Operational excellence is in our DNA. In the phase of conducting your clinical activities the study sites will be initiated, first patients will be enrolled and clinical data is collected

Read more
QServe-phase-clinical data

PHASE

CLINICAL DATA

Our clinical data managers and statisticians analyse the collected clinical datapoints and provide you the results. Our medical writers can help write study reports and publication

Read more

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