Clinical Development

Combining the regulatory requirements with clinical demand.

In Clinical Development, the Qmed team strives to analyse your device-specific functions and claims and use that device knowledge to bridge the justifications and rationales for the demand of clinical studies. It is a multi-facet assignment to address all requirements and demands coming from manufacturers, regulators and clinicians, in Clinical Development we bridge all of them in your documentation and find the most appropriate clinical demand.

The documents that Clinical Development produces for you:

Clinical Evaluation Plan
Clinical evaluation Report
Clinical Development Plan
Post Market Suvaliense Plans and Reports
Post Market Clinical Follow-up Plans and Reports.
Literature searches specialized in Medical devices.

Documents that Clinical Development gives input to:

Study protocols and Investigator Brochures.
Risk Management analyses.
Device Description

At Clinical Development we are working with manufacturers at all stages in their development and post-market activities, we adapt to our requirements to give you the best service.

Clinical Affairs

Strategic consulting

Knowledge Hub

Academy

1:1 Benefit Risk Assessment

Crash course in how to conduct a clinical evaluation according to MDR

1:1 Device Classification

Clinical Development

How can we help you?

Your trusted partner

Contact information

Our services

Working with us

Our expertise