Conducting Clinical Studies is one of the largest expenses of getting an emerging device to market. Developing a Clinical Evaluation Plan, executing it to meet commercial milestones and delivering valued analysis for commercialization is our expertise. Lack of cooperation, coordination and complaince during this process is what causes unnecessary waste. We know it takes time to build genuine trust but our starting point is real and open dialogue about your Clinical Affair service needs.
With the increase in global regulation, there is a greater need for innovative study designs. Our multilingual team is trained in ICH-GCP as well as ISO 14155 and able to support the full lifecycle of regulatory approvals and monitoring. With over 100 years of combined experience, we are one of the most talented teams in the medical device clinical research market. Backed up by our accredited QMS system, we can ensure the quality is maintained regardless of the size and location of your study.
As a medical device Contract Research Organization (CRO), Qmed Consulting offers the following comprehensive selection of strategic consulting services for all types of medical device & IVD clinical studies.
We perform: First in Man, Pre-approval clinical investigations, Post Market Clinical Follow Up, Performance Evaluations and Registry studies.
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 clinical investigation carried out before market approval of the investigational device.
The Pre-market Clinical Investigation is designed and planned to verify the medical device safety and performance objectives and clinical claims identified in the Clinical Evaluation process.
For post-market clinical investigations, the principles set forth in ISO14155:2020 document are intended to be followed as far as relevant, considering the nature of the clinical investigation. According to the standard a post-market clinical investigation is carried out following market approval of a medical device, and is intended to answer specific questions relating to clinical performance, effectiveness or safety of a medical device when used in accordance with its approved labelling. Several points of the standard compared to pre-market studies can be avoided under post-market settings that can make these investigations administrative more simple.
Be aware that if marketed products are being investigated for new indications, other than described in the approved labelling, normative directions for pre-market clinical investigations apply.