Planning and Support

Portable defibrillator
TRaC can help you classify your product correctly and identify the regulatory requirements that apply to your intended market.

Our medical regulatory affairs experts help manufacturers of electrical medical devices by planning and supporting product testing, registration, bespoke training, quality management systems and approvals, as well as helping to secure international and country-specific regulatory assurance and compliance.

We can help you get your product to the global market by providing guidance on all kinds of global approvals for medical devices including: 

  • CE Marking
  • ISO 13485
  • ISO 9001
  • FDA
  • FDA QSR

We can also assist with global registration documentation for medical regulatory affairs by providing support with the following: 

  • CE technical files
  • Design dossiers
  • On–site regulatory support

And we help manufacturers with the following processes for their electrical medical devices: 

  • Identifying applicable harmonised standards
  • Classifying the medical device
  • Risk management
  • Communication with a Competent Authority
  • Global registration documentation and process requirements
  • Review or design of IFU/DFU
  • Register of medical devices with the appropriate Competent Authority
  • Clinical investigations reports and management
  • Selecting a Notified Body
  • Post market surveillance and vigilance procedures

To learn more about how we can support your planning for medical regulatory affairs, email your specification and requirements to contact.us@element.com, enter your details into the blue form or call us on the number in the top right corner of this page.