Clinical Affairs

Qmed - your full service medical device CRO

Collaboration, Alignment, and Adherence

Conducting clinical studies represents a substantial investment in bringing emerging devices to market. Our strength lies in crafting a meticulous Clinical Evaluation Plan, executing it to meet pivotal commercial milestones, and delivering insightful analyses crucial for successful commercialization. The absence of cooperation, coordination, and compliance in this process often leads to unwarranted resource wastage. We understand that establishing trust takes time, but we begin with open and candid discussions about your clinical affairs service requirements.

How We Can Facilitate

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:

  • First in Man
  • Pre-Approval Clinical Investigations
  • Post-Market Clinical Follow-Up (PMCF) studies
  • Performance Evaluations (IVD)
  • Registry Studies

Clinical affairs

CRO services have been fundamental for Qmed Consulting since 206, with over 500 completed studies within all device risk classes.

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Live Phase

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Pre-Market Research

Bringing Your Medical Device to Market

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.

We act as your full service CRO!

Post-Market Research

Maintaining Your Medical Device in the Market

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.

How Qmed Can Assist You

Please note that if marketed products are being investigated for new indications, beyond those described in the approved labelling, normative guidelines for pre-market clinical investigations apply.
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