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ISO 13485 Certified Contract Manufacturing

One of our manufacturing partners is a single source FDA registered and ISO 13485 certified finished medical device contract manufacturing firm, offering single use device, non-sterile reusable devices and in-vitro diagnostic assembly, testing, packaging, sterilization and distribution. Class I, II and III medical devices:

  • Critical care
  • Cardiology
  • Operating Room
  • Cardic Cath Lab
  • Respiratory Therapy 
  • Emergency Room 
  • Neurology 
  • Oncology 
  • Labor & Delivery 
  • Chronic Care 
  • Clinical Laboratory Sleep Labs 
  • Audiology
 
Image of Darcoid medical device ISO 13485 certified

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