Get your SaMD to market 3 times faster. Guaranteed.

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

  • Most SaMD approvals take 18 months. We do it in 6.

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

  • You reach market a full year ahead of schedule, hitting revenue targets and gaining market share.

  • If we don’t succeed, we compensate you. We're so confident that we put our own money on the line.

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

How our accelerated SaMD market access programme works

  • Step 1 - Development of a bespoke execution plan specific to your product, timelines & commercial goals
  • Step 2 - We initiate essential pre-clinical testing and verification on your behalf, eliminating barriers from rapid progress
  • Step 3 - Parallel regulatory filing production and Notified Body evaluation. A precision workflow enables both to run in tandem, carving months off a standard runway.
  • Step 4 - You achieve full certification & market entry within 6 months: guaranteed delivery, or we compensate you.

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