Medical Device Reporting

Specializing in ISO 14971 

 

Clinquest is a Healthcare Product Development Organization and Specialty Contract and Consulting Service Provider for medical device development, particularly those in the Class 2 and 3 categories. We are also part of a Medical Device Association with services for the development and registration of medical devices.

Core Activities:

  • Regulatory Consulting and Filing support
  • 510(k)
  • IDE
  • PMA
  • Preclinical and Clinical Studies
  • Risk Management Plans
  • Vigilance and Incident Reporting Services
  • Medical Device Reporting (MDR) of Adverse Events

Clinquest’s specific strengths for early stage medical device development are:

  • Regulatory Consulting and Support
    • Regulatory strategy
    • Pre-IDE support
    • IDE and PMA applications
    • Support 510(k) applications
    • FDA registration and US Agent services
  • Preclinical and Clinical Trials
    • Preclinical testing strategy and project management
    • Clinical trial design (IDE studies) and implementation
    • Clinical trial implementation, monitoring and project management
    • Data Management and Statistics
    • In vitro diagnostics (IVD) clinical validation studies
  • Risk Management Plans (ISO 14971)
    • Risk and hazard analysis
    • Safety reporting

We also provide:

  • Vigilance Services for Marketed Products
    • Safety Surveillance and vigilance reporting
    • Adverse Event and Complaint management
    • Medical Device Reports
    • Consumer complaint tracking and reporting


With a European office, we can also provide consultants and services that can help our clients to comply with Clinical Summaries, EU directives and CE Mark approval systems as well as establishing testing and quality control systems.

Free White Paper -

Successful Medical Device Development: Critical Factors

Free Presentation -

Preparing for an IDE Application

Free Presentation -

Risk Assessments in 510K Clinical Studies

Free Presentation -

New Safety Reporting Requirements: Dissecting the FDAs Final Rule