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: 360° PMCF Strategy Review

Post-Market Clinical Follow-up (PMCF) is the continuous process of pro-active clinical data collection of a CE-marked device. From the moment your device is placed on the market and used in clinical practice, real-world data are being generated. Qserve CRO can help you collect and use these data for life cycle management of your device. We are specialized in collecting clinical data in a practical and compliant manner for the benefit of (continued) CE-marking of medical devices.

Our experience with Notified Bodies and the regulatory requirements in Europe combined with hands-on clinical operational excellence will ensure high-quality clinical data that meets the regulatory requirements.

Selecting the appropriate PMCF methodology there are multiple options; clinical studies, registries, retrospective data collection, user surveys and others. Each method comes with its own spectrum of data quality, resource requirements, risks and benefits.

Read more
Wiebe Postma Qserve CRO

Qserve CRO reviews your PMCF strategy and provides suggestions for improvement, shares experience, and reviews for regulatory and clinical compliance.

Conditions:

  • Fixed price EUR 2450 (per product)
  • Share your product CER, PMCF plan and related PMCF activity documentation
  • Qserve CRO clinical consultant reviews and provides valuable comments
  • Review includes: suggestions for improvements, sharing experience we gained, regulatory and clinical compliance to MDR and other relevant standards (MDCG/ISO/…etc.)
Contact us

New: 360 degrees PMCF Strategy Review

Post-Market Clinical Follow-up (PMCF) is the continuous process of pro-active clinical data collection of a CE-marked device. From the moment your device is placed on the market and used in clinical practice, real-world data are being generated. Qserve CRO can help you collect and use these data for life cycle management of your device. We are specialized in collecting clinical data in a practical and compliant manner for the benefit of (continued) CE-marking of medical devices.

Our experience with Notified Bodies and the regulatory requirements in Europe combined with hands-on clinical operational excellence will ensure high-quality clinical data that meets the regulatory requirements.

Selecting the appropriate PMCF methodology there are multiple options; clinical studies, registries, retrospective data collection, user surveys and others. Each method comes with its own spectrum of data quality, resource requirements, risks and benefits.

Read more

Qserve CRO reviews your PMCF strategy and provides suggestions for improvement, shares experience, and reviews for regulatory and clinical compliance.

Conditions:

  • Fixed price EUR 2450 (per product)
  • Share your product CER, PMCF plan and related PMCF activity documentation
  • Qserve CRO clinical consultant reviews and provides valuable comments
  • Review includes: suggestions for improvements, sharing experience we gained, regulatory and clinical compliance to MDR and other relevant standards (MDCG/ISO/…etc.)
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

News

All articles