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A step-by-step guide to achieve your medtech milestones


The best way for us to share our ISO 13485 certified development process with you is through a series of videos. Within these videos, we will walk through our phase based process maps, which have been trialed, tested, and optimized through over a decade of focused medical device development. Within these videos, we will walk you through the technical, quality, clinical, and regulatory steps needed to achieve your critical medtech milestones. 


  • Assessment & Planning Phase
  • Concept Design & Prototyping Phase
  • Detailed Development & EVT Phase
  • Verification & Validation Phase
  • Design Transfer Phase

Our Medical Device Development video series is provided to you for free. While Archimedic's quality management system (QMS), inclusive our medical device development process, is ISO 13485 certified, you will need audits, documentation controls, and other quality measures to ensure compliance with the applicable regulatory standards.