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

Contact us today

Why Mantra Systems?

We are your partner to full approval, solving regulatory challenges through tailored routes to compliance

Medical Device Subject Matter Experts

What you get with Mantra Systems…

  • Experts in all types & classes of device
  • Personalised project plans to suit your needs
  • Named project lead to support you throughout
  • Flexible payment options with no hidden costs
  • Direct & constant visibility of project progress
  • Regulatory professionals & real medical experts
  • Unlimited post-submission support until approval

Contact us today to book a free consultation

Are you looking for…

  • Expert FDA 510(k) consultants?
  • A quote for our services?
  • Help understanding your options?

Whatever you need, contact us today for a same-day quotation.

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