FDA 510(k) Medical Device Consulting Services

  • Market-leading regulatory affairs professionals
  • Personalised MDR ↔ FDA 510(k) transition service
  • Achieve US market access for your medical devices

Get in touch

Please contact us to discuss your FDA 510(k) submissions in more detail.

Enquire today

  • 310+ Satisfied Clients
  • 77% Return Customers
  • 100% Notified Body Approval

Why Mantra Systems?

We'll help you overcome the key steps in medical device approval ensuring market access for your products

Medical Device Subject Matter Experts
  • Experts in all areas of medical device regulation
  • Professional consultants for worldwide markets
  • Working with all types & classes of medical device
  • Leading medical device regulatory consulting services
  • Guidance & support with Non-Conformity Reports
  • Fixed timelines + commitment to meet your deadlines
  • Named project lead to support you throughout
  • Direct & constant visibility of project progress
  • Unlimited post-submission support until full approval

Contact us

Our Clients say

Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisals for our medical devices; I would thoroughly recommend them.

TD

Dr. Trevor Day Principal Scientist Procter & Gamble

Close

Let's talk

Send an enquiry or book a free discovery meeting to see how we can support your market access strategy