Regulatory Affairs

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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

Q-Trials offers a full range of regulatory assistance and support for medical device companies. Key services include:

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