Clinical Development

Harmonizing Regulatory Requirements with Clinical Needs

Within Clinical Development, the Qmed team undertakes the intricate task of analyzing the unique functionalities and claims of your medical device. Leveraging this in-depth device knowledge, we establish the justifications and rationales necessary to address the demands for clinical studies. This multifaceted endeavor entails satisfying the requirements and expectations from manufacturers, regulators, and clinicians, and in Clinical Development, we seamlessly integrate them into your documentation while identifying the most appropriate clinical needs.

The Document Portfolio Crafted by Clinical Development Encompasses:

  • Clinical Evaluation Plan
  • Clinical Evaluation Report
  • Clinical Development Plan
  • Post-Market Clinical Follow-up Plans and Reports
  • Literature Searches Pertaining to Medical Devices

Furthermore, Clinical Development Contributes Input to:

  • Study Protocols and Investigator Brochures
  • Risk Management Analyses
  • Device Description
  • Labelling
At Clinical Development, we collaborate with manufacturers at all stages of their development and post-market activities, customizing our approach to meet your specific requirements and provide the highest quality of service.
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