Med'In QARA - Clinical evaluation
Clinical strategy based on applicable standards
Optimize your clinical strategy for regulatory compliance
To demonstrate the safety and performance of your devices, an in-depth clinical evaluation is required, in addition to pre-clinical investigations.
In order to guarantee the excellence of this support, I have established a contractual partnership with MedTech SMEs, founded by Dr. Danielle Nusimovici-Avadis, a converted doctor specializing in clinical support for regulatory purposes (over 22 years' experience in the sector), and with a highly qualified multidisciplinary team of doctors, clinical research associates and biostatisticians.
Together, we help you meet the requirements of regulatory standards, including those of Regulation (EU) 2017/745, while ensuring smooth coordination and total transparency.
Our integrated approach
The approach we propose is designed to fit in with your regulatory strategy, and articulate with your design, risk management and regulatory files.
We work closely with your team (Clinical Affairs department, Medical Reviewer...) to organize, structure and document all the clinical evidence for your device.
Our support in several key stages
Clinical Evaluation (CEP/CER)
Research and review of scientific literature
Clinical Development Plan (CDP)
Clinical investigations
Documentary reconciliation
Summary of safety and clinical performance characteristics (SSCP)
Post-Marketing Clinical Follow-up (PMCF)
Why entrust your clinical strategy to our team?
By working with a multidisciplinary, complementary and specialized team to establish your clinical evaluation process, you have access to cutting-edge, dedicated expertise. This approach ensures that all regulatory requirements for Clinical Evaluation of medical devices, including those of Regulation (EU) 2017/745, are met, while enabling more flexible and responsive management.
With us, you benefit from structured, coordinated and efficient support, which reduces your clinical compliance times and secures your operations in different markets (Europe, US...).
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