Your Audit-Proof Foundation

For a startup, speed is everything. But moving fast without a compliant QMS is a recipe for future roadblocks. We specialize in building lean, scalable Quality Management Systems that meet the full requirements of ISO 13485 and the FDA QMSR without burying your team in bureaucracy. Our coaching model ensures the final system is a perfect fit for your business.

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What You Get

  • A phased, practical plan to build your QMS from the ground up.
  • Custom-drafted, AI-accelerated Standard Operating Procedures (SOPs).
  • A streamlined and easy-to-manage document control system.
  • A scalable framework that is ready for your company's future growth.