QMedCo Consulting Services
As an international CE Consultancy, QMedCo is dedicated to provide professional, dedicated and highly personalised support to its clients. With decades of experience in clinical evaluation and clinical expertise, QMedCo delivers an unparalleled approach and focus on European market entry and CE mark certification, offering several clinical evaluation services at different stages of the product development to achieve a comprehensive and well designed clinical evaluation to produce robust clinical evidence.
Clinical Evaluation Services
Pre market phase
In the pre market phase of medical device development, a clinical literature review is conducted to comprehensively analyse existing relevant studies, data, and published literature. The clinical evaluation strategy outlines the overall approach for assessing the device's safety and performance during clinical trials. A clinical evaluation plan then provides a detailed roadmap, specifying the data collection methods, patient selection criteria, endpoints, and statistical analysis.
Clinical Phase
QMedCo provides comprehensive solutions for the clinical stage of medical device development. Our services include assistance with clinical evaluation report preparation, MDR compliance, CE marking, as well as data analysis & appraisal. Get your device certified with our knowledgeable and experienced team.
Post Marketing Clinical Follow-up (PMCF)
PMCF is a critical component of the Medical Device Regulation (MDR). It involves systematic and proactive collection of clinical data from real-world use of medical devices after they have been placed on the market. PMCF aims to continuously assess the device's performance, safety, and efficacy throughout its lifecycle.