Home >> Services >> Regulatory Affairs
Regulatory Affairs
Q-Trials provides consulting services in the fields of medical devices and technologies. We are ideally-positioned to enable companies comply with the requirements of worldwide regulatory authorities. Our full range of regulatory and clinical consulting services are tailored to meet client-partners’ specific needs, in a one-stop-shop format. Regulatory Affairs Services
Regulatory Strategy
Development and implementation of regulatory strategy Determining optimal regulatory route Intended use and indications for use Product classification and road map Regulatory opinion regarding product development
Regulatory Submissions
Preparation and submission of regulatory applications:
Investigational Device Exemption (IDE) & Pre-IDE Pre-market notifications [510(k)s[ Pre-market approval (PMA(
Technical Filing Interactive work with regulatory authorities in Israel and internationally Communications and meetings with FDA and other regulatory bodies.
Other Regulatory Requirements
Preparing risk analysis management files Performance test design (protocol and summary report( Plan for biocompatability and sterilization tests
Medical Writing Pre-Clinical Studies
Evaluation and assessment of pre-clinical programs Evaluation and selection of laboratory organization(s) Preparation of study and summary reports Preparation of pre-clinical sections of IDE, 510K, and PMA applications
Clinical Studies
SOPs for clinical study Design of study Preparation of Clinical Investigation Package Preparation of all study log-books and forms required for study management Preparation of study and summary reports
