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.

Dedicated medical device

Dedicated to all phases of clinical development, including PMCF

Dedicated to clinical data collection that will satisfy the regulator

Dedicated to quality and efficiency

Dedicated teams with short communication lines

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.

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.)