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When it comes to patient care, the medical field is quite delicate. The medical devices sector has its own set of standards, laws, and certifications that it must adhere to. Each step was taken to ensure quality, safety, and, most importantly, legal conformity. The particular steps that medical device manufacturers must take are not spelled out in the ISO 13485 certification. Nonetheless, the certification ensures the public that rigorous standards are maintained throughout the production of medical equipment. There are several advantages to adopting ISO 13485 for your company. Maintaining an ISO 13485 quality management system will require some more work up front, but the payoff is greater efficiency and happier clients.

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