Medical Regulatory Affairs

Medical Device
We provide consulting for Electrical Medical Device regulatory affairs to manufacturers to help them achieve compliance with global medical regulatory requirements.

TRaC’s experts (scientists, engineers and regulatory advisors) consult with manufacturers on regulatory strategies for existing and new products, focusing on device commercialisation, management system implementation and the preparation of documentation. We also offer a comprehensive portfolio of training in key areas of regulatory affairs to help companies understand and develop their own regulatory strategy and develop products in the most cost-effective and flexible way.

TRaC’s technical experts understand the challenge of exporting medical products to the global market and assist manufacturers to achieve increased speed to market and successful product launches by providing the following services:

  • Bespoke training
  • Managed test programs
  • Planning and support
  • Documentation review and assessment
  • Managing product and QMS approvals.

Our medical regulatory affairs experts help manufacturers of medical devices with product registrations, quality management systems and approvals and can help secure international and country-specific regulatory assurance and compliance for your products. We can help with global approvals for medical devices and assist you in getting your product to the global market by providing guidance on:

  • CE Marking
  • FDA
  • FDA QSR
  • ISO 13485

To learn more about how our medical regulatory affairs consultancy can add value to your medical product development, contact us on quoteme@tracglobal.com, enter your details into the blue form or call us on the number in the top right corner of this page.