Case Study: Dual management system certification to ISO 13485 and ISO 9001 paves way for medical 3D printing technology into the European Union (EU)

Case Study: Dual management system certification to ISO 13485 and ISO 9001 paves way for medical 3D printing technology into the European Union (EU)In the highly regulated European Union (EU) medical device industry, stringent quality and legal demands are placed on medical device manufacturers before they are allowed to sell their products. Find out why Oceanz, a professional 3D printing company, decided to obtain certification against ISO 13485 in addition to their existing ISO 9001 certification and what factors drove this decision including:

  • Global harmonization
  • Differentiating themselves in a highly competitive market
  • Fostering a deeper sense of ownership in employees to provide a high level of quality, safety and consistency

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