Accelerated SaMD & AIaMD Regulatory Approval

For SaMD teams where speed to market is business-critical

Built for Speed. Backed by Results.

Our approach inverts the standard certification model to eliminate the sequential delays that slow most SaMD approvals. Complete the form to find out if your product qualifies for a Free Feasibility Review.

Free Feasibility Review

To discover whether this service is right for you, we offer a free, no-obligation Feasibility Review.

Complete the form and a member of our team will be in touch to arrange your review.

Specialised SaMD & AIaMD Support

Expert guidance for medical device developers navigating certification with greater speed and predictability.
Parallel Workstream Methodology

Our accelerated approach runs multiple simultaneous workstreams, cutting delays and maximising efficiency throughout.
Early Notified Body Engagement

Integrating technical file development with upfront Notified Body involvement significantly reduces approval timelines.
Proven, Accelerated Results

Clients achieve approval up to 3x faster than standard, with Class I entry in under four weeks.

What Our Clients Say

I would recommend Mantra Systems without hesitation to any software medical device company looking for a regulatory partner that combines genuine MDR depth with a real-world understanding of software.

Sarankan Sivakanesan COO & Co-Founder Noteless
Not only were Mantra Systems very easy to work with, but their clinical knowledge and dedication to helping us meet the tight timelines for response was top notch.

Courtney Regulatory Affairs Manager Northgate Technologies

Your Questions Answered

Who is this service for?
- Class I SaMD seeking immediate market entry
- Class IIa/IIb SaMD manufacturers focused on accelerated approval
- Products at a mature stage of design with testing data available
- Funded teams seeking a rapid return on investment
Why was this accelerated certification service developed?

Working with hundreds of innovators revealed a consistent demand for faster, more streamlined routes to market. Rather than accept lengthy timelines as inevitable, we identified the root causes and built a service specifically designed to eliminate them.
What causes delays in the standard approval process?

The most common culprits are inadequate preparation, incomplete technical files, weak clinical evidence, a disconnected QMS, and a sequential process where submissions, reviews, and responses happen one after another — each adding weeks or months to the timeline.
How does your approach solve these problems?

We invert the standard model. Strategy, QMS, and technical file development are fully integrated from the outset, ISO 13485, 14971, and 62304 compliance is embedded throughout, and document review cycles run concurrently rather than sequentially — removing the bottlenecks that cause the most significant delays.

Also, with over 300 successful MDR submissions and a deep experience in supporting SaMD and AIaMD products through UK and EU MDR certification, we know what it takes to get approval.
How much faster can approval actually be achieved?

Our clients have achieved full approval up to 3x faster than the industry standard. Class I devices have reached market in under four weeks, though timelines vary depending on device classification and complexity.
How do I find out if this service is right for my product?

We offer a free SaMD Acceleration Feasibility Review to help assess your pathway and identify where time can be saved. Contact our team to arrange your Feasibility Review.