Get your SaMD to market 3 times faster. Guaranteed.

For high-velocity medtech teams where time-to-market is existential.

  • Accelerate SaMD approvals up to 300% and reach market a full 12 months earlier than industry standard.

  • No shortcuts. No compromise. Just a proven, precision-engineered process that gets you to full certification 3x faster than elsewhere.

  • Gain market share and first mover advantage ahead of the competition.

  • Fully guaranteed. We promise to hit your timelines and offer financial warranties to prove it.

Who is this for?

  • Funded teams under intense delivery timelines
  • Scale-ups needing to launch without any delay
  • Founders committed to quality alongside speed of execution
  • Developers of medical device software, SaMD or AIaMD
Watch our 3 minute explainer for this service.

How our accelerated SaMD market access programme works

  • Step 1 - Accelerated execution plan. Our team craft a bespoke strategy for full approval at maximum velocity, specific to your product, timelines and commercial goals.
  • Step 2 - QMS and regulatory file development. Our dedicated project team produces all necessary documents and processes for regulatory submissions in your target markets. You have full oversight against agreed timelines.
  • Step 3 - Our team work alongside the Notified Body to ensure scrutiny of the submission is performed with maximum efficiency, with comments and resolution conducted in parallel.
  • Step 4 - We guarantee to hit your timelines through a transparent and open risk-share approach.

Get started today

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