In an era of ever-changing global regulations, innovative study designs are in high demand. Our multilingual team is well-versed in ICH-GCP, FDA CFR, ISO 14155 standards and other national regulations, capable of supporting the entire regulatory approval and monitoring lifecycle. With a collective experience spanning over a century, we stand among the most accomplished teams in the field of medical device clinical research. Bolstered by our accredited Quality Management System (QMS), we ensure high quality standards are maintained, irrespective of your study’s scale or geographical location.
As a distinguished medical device Contract Research Organization (CRO), Qmed Consulting extends a comprehensive array of strategic consulting services tailored to various medical device and In Vitro Diagnostic (IVD) clinical studies.
Our portfolio encompasses a spectrum of studies for all classes of products (medical device class I to III), including:
CRO services have been fundamental for Qmed Consulting since 206, with over 500 completed studies within all device risk classes.
Pre-market clinical investigation is a crucial step conducted before obtaining market approval for an investigational device. It is meticulously designed and executed to validate the safety and performance objectives, as well as the clinical claims identified during the Clinical Evaluation process.
For post-market clinical investigations, adherence to the principles outlined in the ISO14155:2020 and other regulations and guidelines is recommended, as far as they are relevant, taking into account the nature of the clinical investigation. According to this standard, post-market clinical investigations are conducted subsequent to the market approval of a medical device. Their purpose is to address specific inquiries concerning the clinical performance, effectiveness, or safety of a medical device when used in accordance with its approved labelling. In comparison to pre-market studies, post-market investigations may benefit from certain exemptions outlined in the standard, making these studies administratively simpler.