- 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
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
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310+ Satisfied Clients
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77% Return Customers
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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
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.
TDDr. Trevor Day Principal Scientist Procter & Gamble