CQT Solutions can provide solutions to both large multi-nationals and small start-ups throughout Europe. We know what the regulators and the notified bodies expect. We are well positioned to provide you with the assistance that suits your organization. Some of the solutions that we provide are as follows:

  • QMS Implementation
  • QMS remediation
  • Product Design & Development
  • Conducting Usability Studies
  • Preparing Design Dossiers and technical files
  • Risk Management
  • Computer Software Validation
  • Process Development and Validation
  • Regulatory Submission and strategies
  • Supplier on-boarding
  • EU MDR gap analysis
  • Mock inspections and Audits
  • FDA and European enforcement action support

We can provide you with the solutions in the above areas in a timely and compliant manner.  This support can be either consultancy or more hands-on if required.