Clinical validation is one of the most important and critical aspects of demonstrating that the medical device or IVD works as intended. While there are many ways in which clinical testing can be conducted and the consolidated reports can be generated, however in order to have the data deemed acceptable by the regulatory bodies, it must be conducted in accordance with a clinical trial protocol that has well defined primary and secondary end points, thought through study design, statistical data analysis plan, and sample size.
Clinical protocol development, tying the clinical protocol with the regulatory strategy, creating Clinical Evaluation Reports (CERs), and integrating clinical operations into the Quality Management Systems (QMS) of companies has been our focus for the past several years.
The Biostatisticians, MD Physicians, Radiologists, Medical Writers, Engineers, Quality and Regulatory professionals at Elexes have been helping medical device companies conduct GCP compliant studies which allowed them to collect enough evidence to prove the safety and efficacy of the device.
Pre-market and Post-market Clinical Requirements
Amongst the various premarket and post market studies and report creation that Elexes has assisted with, the following have been the most important ones:
- Appointment of a Medical or Clinical Director
- Clinical evaluation report (CER) creation as per the MedDev 2.7.1
- Post Market Clinical Follow up (PMCF) protocol
- Review of clinical data to evaluate appropriateness for approvals
- Clinical protocol and report as per ISO 14155 and Good Clinical Practice (GCP)
- Clinical operations procedures to set up in house clinical studies
- Creation of Scientific Publication Dashboard
- Medical and scientific content and videos for potential user engagement
- Key Opinion Leader (KOL) identification and engagement
- Postmarket surveillance strategy and execution
- Complaint handling and corresponding systems set up
By being 100% focussed on the medical device and IVD space, Elexes has been generating quality results for companies in the field of clinical studies and clinical evaluation report creation. Partner with us to get the benefit of our hands on experience, get these documents and reports in place accurately in one go and save your valuable time.
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