Regulatory Affairs

Qsite provides a full range of regulatory assistance and support to medical device companies. Our key services include:

Key Regulatory Services:

  • Developing and Implementing Regulatory Strategies
  • Determine the optimal regulatory route
Preparing and Submitting Regulatory Files such as:
  • Pre-market notifications [510(k)s]
  • Pre-market approval (PMA)
  • Investigational Device Exemption (IDE) applications
  • Device reclassification petitions
  • CE submission
  • Technical files for EU marketing
  • Canadian device license applications
  • Developing and Implementing Regulatory Strategies
  • Determine the optimal regulatory route

Implementation of regulatory requirements in the R&D process:

  • Risk analysis and management
  • Design of performance test (protocol, statistical analysis and summary report)
  • Define biocompatibility and sterilization tests
  • Guidance of safety and EMC tests

Communication and meetings with FDA and other regulatory authorities.

Global Representations:

  • U.S agent
  • The FDA requires all foreign firms wishing to market medical products in the USA to appoint a US agent. Accordingly, we can provide these services:
    • Assign a US address, phone and fax for non-US companies
    • Assist the FDA in communicating with international medical device companies
    • Receive documents from the FDA on behalf of your company
  • EU Authorized Representative
  • The European Union requires all foreign firms would like to market medical products in the EU to appoint an Authorized Representative to be responsible towards the European Authorities for all European Regulatory Affairs. The European Representative address must appear on the product label, or the outer packaging, or instructions for use. Qsite can provide these services:
    • Notify your product to the Competent Authority in order to apply for CE-Marking
    • Provide a European Business Address as required by the Directive
    • Maintain the technical documentation for routine inspection by the European Competent Authorities
    • Ensure the communications between the European Competent Authorities and the manufacturer
    • Observe the manufacturer's compliance with the European Directive
    • Supply the competent authority with a Medical Device Report (MDR) as required

Turning your product into reality