FREE 1:1 FDA to MDR strategy planning session
Worth up to $2,500We'll explore how you can leverage your FDA approval to secure a CE-mark under EU MDR / IVDR and open up new markets in Europe.
- A bespoke EU approval strategy built to meet your priorities
- Avoid duplication of work and prioritize speed and efficiency
- Make best use of existing FDA approval and market traction
- Gain clarity on any new clinical evidence requirements
- Explore the feasibility of translating 510(k) approval into EU certification through the equivalence route.
This is NOT a generic strategy. This is a complete, fully-written and customized plan developed specifically for your products and commercial goals.
You’ll also get:
- Direct contact with our regulatory professionals for any questions or concerns
- Targeted advice on resolving any gaps found in clinical evidence
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We understand that trust needs to be earned before it is granted. By offering this for free, we’re aiming to:
- Showcase the quality of our work and standard of our team
- Demonstrate why we have a 100% success rate under EU MDR & IVDR
- Form new business relationships with US-based companies built on trust and value
- Directly support US innovators who are advancing healthcare
This offer is about proof over promise. By providing value first, we are working to develop relationships and further enhance our position as market leaders in EU medical device regulatory consulting.
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This offer is limited to medical device manufacturers based in the US.
It’s specifically intended for:
- US companies with existing FDA approvals for their medical devices or IVDs
- Actively considering pursuing EU MDR / IVDR approval or are already working on a submission
- Any class of medical device.
It’s available for both hardware and software medical devices.
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No – this is a genuine offer that’s free of charge with no ongoing obligation. You are completely free to use the strategy report independently in your MDR submissions.
The work will be conducted in strict confidence. We are happy to work under NDA - you will be provided with an email address for correspondence when you confirm your kick-off call.
If you have any further questions, please email contact@mantrasystems.com or call +441142998889 to speak directly with one of our specialists.
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Act today – this is a time limited offer.
Confirm that you qualify using the form - it will give you an instant decision.
Once qualified, we’ll provide you with a direct calendar link to book a workshop at a time of your convenience. All slots account for the time difference between US and UK. Workshops are scheduled to last 1 hour. Following this, our team will produce your personalized strategy report and send it through to an email of your choosing. It’s yours to keep.
Get started today – this offer can’t last forever.
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We work under strict confidentiality and are happy to conduct calls under NDA / CDA. We are ISO 9001 Certified and members of TOPRA.